Assessment of the Safety, Tolerability, and Pharmacokinetic of HM201
Study Details
Study Description
Brief Summary
This will be a single centre, Phase 1, Placebo-controlled, Randomized, Doubleblind, SAD & MAD Study to Assess the Safety, Tolerability and PK of HM201 in Healthy Subjects.
Condition or Disease | Intervention/Treatment | Phase |
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Early Phase 1 |
Detailed Description
Objective of the study is to assess the safety, tolerability, and PK of single and multiple intravenous administration of HM201. The study design consists of a SAD study of 4 cohorts, 8 subjects each cohort and a different dose level per cohort. In each cohort 2 will receive the placebo while rest of group will be administered with HM201. A total of 32 subjects are planned for the SAD study.
MAD part will begin after cohort 1 and 2 of SAD is completed. MAD will consist of 9 subjects; 2 will receive the placebo while 7 will be administered with HM201. MAD will be conducted in a dose escalation manner with 4 weekly doses administered to all subjects. One randomization scheme will be produced for each cohort separately.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: SAD Cohorts 1 to 4: Participants receiving HM201 Each SAD cohort participant will be randomized to receive 1 of 4 escalating doses (0.01 mg/kg (2 nmol/kg); 0.03 mg/kg (5 nmol/kg); 0.06 mg/kg (10 nmol/kg); 0.12 mg/kg (20 nmol/kg). |
Drug: HM201
HM201 will be administered intravenously.
Other Names:
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Placebo Comparator: SAD Cohorts 1 to 4: Participants Receiving Placebo Each SAD cohort participant will be randomized to receive placebo. |
Drug: Placebo
Placebo will be administered intravenously.
Other Names:
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Experimental: MAD Cohorts 1 to 4: Participants Receiving HM201 Each MAD cohort participant will be randomized to receive a once a week dose of 1 of 4 escalating doses (0.01 mg/kg (2 nmol/kg); 0.03 mg/kg (5 nmol/kg); 0.06 mg/kg (10 nmol/kg), 0.12 mg/kg (20 nmol/kg) for 4 weeks. |
Drug: HM201
HM201 will be administered intravenously.
Other Names:
|
Placebo Comparator: MAD Cohorts 1 to 4: Participants Receiving Placebo Each MAD cohort participant will be randomized to receive placebo once a week for 4 weeks. |
Drug: Placebo
Placebo will be administered intravenously.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number and percentage of treatment-emergent adverse event, serious adverse event and discontinuation. [Up to 15 days post last infusion for both SAD & MAD]
Secondary Outcome Measures
- Plasma concentrations of HM201 [SAD: Up to Day 15. MAD: Up to Day 36]
- Pharmacokinetic assessment 1 [SAD: Up to Day 15. MAD: Up to Day 36]
Area under the plasma concentration versus time curve (AUC)
- Pharmacokinetic assessment 2 [SAD: Up to Day 15. MAD: Up to Day 36]
Peak Plasma Concentration (Cmax)
- Pharmacokinetic assessment 3 [SAD: Up to Day 15. MAD: Up to Day 36]
Time of peak plasma concentration (Tmax)
- Pharmacokinetic assessment 4 [MAD: Up to Day 36]
Concentration at the last planned timepoint prior to dosing (Ctrough)
- Pharmacokinetic assessment 5 [SAD: Up to Day 15. MAD: Up to Day 36]
Mean residence time (MRT)
- Pharmacokinetic assessment 6 [SAD: Up to Day 15. MAD: Up to Day 36]
Drug clearance (CL) & Clearance at steady state (CLss)
- Pharmacokinetic assessment 7 [SAD: Up to Day 15. MAD: Up to Day 36]
Volume of distribution at steady state (Vss) & during terminal phase (VZ)
- Pharmacokinetic assessment 8 [SAD: Up to Day 15. MAD: Up to Day 36]
Half life (T1/2)
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Healthy male or non-childbearing potential female
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BMI ≥18.0 and ≤32.0 kg/m2
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Good health based on past medical history, medication use, vital signs and physical exam.
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Normal renal and hepatic function.
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Female partners of child bearing potential must agree to use contraception.
Key Exclusion Criteria:
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Clinically significant medical history.
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Significant drug allergy.
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Use of experimental drug within 3 months prior.
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Previously received HM201, AM and other derivatives.
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History of old myocardial infarction.
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Diagnosed with malignant tumor or history of treatment for malignant tumor.
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History of drug or alcohol abuse.
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Use of omitted medicines or substance opposing objective of study.
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COVID19 vaccine administered within 14 days of initiation of investigational product or if to receive additional dose within 30 days of investigational product administration.
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Use of tobacco/nicotine in excess of ≥ 5 cigarettes a day and unable or unwilling to prohibit smoking during admission to site.
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Daily consumption of more than 1L of caffeine/xanthine beverage which cannot be discontinued more than 24 hours prior to dosing of investigational product and/or ECG measurement.
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Regular use of nutraceuticals (e.g., St. John's wort, ginseng, ginkgo biloba, Chinese herbs, and melatonin) within 1 week before administration of investigational product.
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Donation of plasma or platelet or 200 mL of whole blood within 4 weeks or 400 mL whole blood within 3 months before administration of investigational product.
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Clinically relevant findings in ECG.
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Systolic blood pressure below 100 mmHg or above 140 mmHg at screening.
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Diastolic blood pressure above 90 mmHg at screening.
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Heart rate below 40 beats/min or above 100 beats/min at screening.
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Symptom of orthostatic hypotension is found at screening or before investigational product administration (Day -1).
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Hepatitis B virus surface antigen (HBsAg), hepatitis B virus core antibody (HBcAb) hepatitis C virus antibodies (anti-HCV) or human immunodeficiency virus (HIV) antigen and antibody at screening.
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Positive to syphilis.
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Positive to urine drug test.
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Positive alcohol breath test.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Nucleus Network Pty Ltd | Herston | Queensland | Australia | 4006 |
Sponsors and Collaborators
- Syneos Health
- Himuka AM Pharma Corp.
Investigators
- Principal Investigator: Kristi McLendon, MD, Nucleus Network Pty Ltd
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HM201-AUS-001