Assessment of the Safety, Tolerability, and Pharmacokinetic of GMA106
Study Details
Study Description
Brief Summary
This will be a single centre, Phase 1, placebo-controlled, randomized, doubleblind, sequential SAD study to assess the safety, tolerability, and PK of GMA106 in healthy subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
The objective of the study is to assess the safety, tolerability, and PK of single GMA106 SC injection. The study design is a standard design for this type of study. This SAD study will consist of 6 cohorts (1 cohort per dose level). Within each cohort, 8 subjects will be randomized in a 3:1 ratio to receive under fasting conditions, either the study drug GMA106, or matching placebo. In each cohort, 6 subjects will be administered GMA106 and 2 subjects will receive the matching placebo, for a total of 48 subjects planned for evaluation in this study. One randomization scheme will be produced for each cohort separately.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: GMA106 6 different dosages will be subcutaneously injected into the abdomen. |
Drug: GMA106 Injection
GMA106 solution for injection. Subjects in each cohort will receive a single injection of GMA106 or matching placebo under fasting conditions and at the following target dose levels.
Other Names:
|
| Placebo Comparator: Matching placebo 6 different dosages will be subcutaneously injected into the abdomen. |
Drug: GMA106 Matching Placebo
Matching Placebo for GMA106
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Nature, incidence and severity of treatment-emergent adverse events [up to 150±5 days post-injection]
Safety & Tolerability of GMA106
Secondary Outcome Measures
- Pharmacokinetic (PK) profile of GMA106 and GMA106 total antibody following single SC administration in healthy subjects. [Up to 30±1 day for GMA106 and up to 150±5 days post -injection for GMA106 total antibody]
Maximum observed concentration (Cmax)
- Pharmacokinetic (PK) profile of GMA106 and GMA106 total antibody following single SC administration in healthy subjects. [Up to 30±1 day for GMA106 and up to 150±5 days post -injection for GMA106 total antibody]
Area under the concentration versus time curve (AUC0-t)
- Pharmacokinetic (PK) profile of GMA106 and GMA106 total antibody following single SC administration in healthy subjects. [Up to 30±1 day for GMA106 and up to 150±5 days post -injection for GMA106 total antibody]
Time of Cmax
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female, light -smoker (≤5 cigarettes or equivalent of nicotine per day within 2 months prior to screening and must abstain from smoking from Screening), > 18 and ≤ 60 years of age, with body mass index (BMI) > 20.0 and < 32.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
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Healthy as defined by:
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The absence of clinically significant (in the opinion of the Investigator) illness and surgery within 4 weeks prior to dosing.
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The absence of clinically significant (in the opinion of the Investigator) history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and chronic condition of the urogenital, reproductive, musculoskeletal, endocrine system, or cancer, or metabolic disease.
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Females of childbearing potential who are sexually active with a male partner must be willing to use at least one contraceptive methods throughout the study (for 150±5 days after study treatment administration)
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Male subjects must agree to avoid causing pregnancy by using at least a reliable method of birth control for 150±5 days after study treatment administration and must be willing to use one contraceptives.
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Male subjects must be willing not to donate sperm during the study and for 150±5 days following study treatment administration.
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Female subjects must be willing not to donate ovules until during the study and for 150±5 days following study treatment administration.
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Participants with same-sex partners (abstinence from penile-vaginal intercourse) are eligible without needing contraception when this is their usual form of sexual relations.
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Capable and willing to give informed consent prior to any study-specific activities/procedures.
Exclusion Criteria:
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Any clinically significant (in the opinion of the Investigator) abnormality at physical examination, abnormal laboratory test results or positive test for HIV, hepatitis B, or hepatitis C found during medical screening. Abnormal laboratory values will include: liver function tests (LFTs) > 1.5x ULN
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Clinically significant (in the opinion of the Investigator) presence of acute illness (e.g., gastrointestinal illness, gall bladder disease [cholecystectomy is allowed], chronic pancreatitis, infection such as influenza, upper respiratory tract infection) upon admission to the study site.
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Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2). History of renal impairment or renal disease and/or estimated glomerular filtration rate ≤ 90 mL/min (as calculated by Cockroft and Gault formula).
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Positive urine drug screen, or alcohol breath test at screening or at admission, positive urine cotinine test at admission.
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Positive pregnancy test at screening or at admission.
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Clinically significant ECG abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 160 mmHg, diastolic blood pressure lower than 50 or over 95 mmHg, or heart rate less than 45 or over 100 bpm) at screening.
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History of type 1 hypersensitivity or severe cutaneous adverse reaction to any medication, or to any excipient in the formulation, or history of significant atopy.
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Women who intend to become pregnant or are lactating.
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History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit (average weekly alcohol intake that exceeds 10 units per week, or are unwilling to stop alcohol consumption for 24 hours prior to study treatment administration until the last PK sample collection of GMA106 of the study on Day 30±1 (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).
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History of significant drug abuse within 1 year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening.
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Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days or 5 x T1/2 whichever is longer prior to dosing, administration of a biological product in the context of a clinical research study within 90 days or 5 x T1/2 whichever is longer prior to dosing, or concomitant participation in an investigational study involving no drug or device administration.
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Use of medications for the timeframes specified below, with the exception of hormonal contraception, medications exempted by the Investigator on a case-bycase basis because they are judged unlikely to affect the pharmacokinetic profile of the study treatment or subject safety (e.g., topical drug products without significant systemic absorption):
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Prescription medications within 14 prior to study treatment administration;
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Over-the-counter (OTC) products and natural health products (including herbal remedies homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 7 days prior to study treatment administration, with the exception of the occasional use of paracetamol/acetaminophen (up to 2 g daily) and ibuprofen (up to 800 mg daily);
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Depot injection or implant of any drug within 3 months prior to study treatment administration.
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Live or live attenuated vaccine within 3 months prior to study drug administration and live or live attenuated vaccine planned over the course of the study.
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COVID-19 vaccine within 14 days prior to study drug administration and within Day 30±1 after study treatment administration.
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Have received chronic (>14 consecutive days) systemic glucocorticoid therapy (except for topical, intra-articular and inhaled preparations) within the last 12 months or have received any glucocorticoid therapy within 30 days before screening.
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Receiving treatment or participation in an organized weight loss program that may cause significant weight gain or loss within 3 months before screening or scheduled within the study duration period.
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Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to study treatment administration.
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Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CMAX Clinical Research | Adelaide | South Australia | Australia | 5000 |
Sponsors and Collaborators
- Gmax Biopharm Australia Pty Ltd.
Investigators
- Principal Investigator: Sepehr Shakib, Prof, CMAX Clinical Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GMA106-I-101