A Phase 1 Study of EXT608 in Healthy Adults
Study Details
Study Description
Brief Summary
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose safety and tolerability study of EXT608 in healthy subjects. There will be up to 6 sequential dose escalation cohorts of 4 participants. In each cohort 3 participants will receive EXT608 and 1 participant will receive placebo.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
This is a randomized, double-blind, first-in-human, placebo-controlled single ascending dose study to study the safety, tolerability, PK, and PD of EXT608 in healthy adult participants.
Participants will be enrolled into 1 of up to 6 planned single dose cohorts in ascending fashion.
Each cohort will consist of 4 participants randomized to receive either EXT608 or placebo, whereby 3 will receive a single injection of EXT608 and 1 will receive matching placebo.
Up to 6 dosing cohorts are planned with no single dose escalation to exceed a 3-fold dose increment. A Data Monitoring Board will review the seven-day safety data in each cohort before authorizing the initiation of the next cohort.
A screening visit will take place within 28 days of dosing. Eligible participants for each cohort will be admitted to the Clinical Research Unit (CRU) 1 day prior to dosing and remain in the CRU through at least 72 hours after dosing for safety and PK assessments before discharge. The total confinement period will be 4 nights, unless extended for management of AEs at the discretion of the Investigator
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental- EXT608 Up to 6 sequential dose escalation cohorts will receive a single dose of EXT608 administered as a subcutaneous injection |
Drug: EXT608
EXT608 is an investigational drug administered via subcutaneous injection
Other Names:
|
| Placebo Comparator: Placebo comparator Up to 6 participants will receive matching placebo administered as a subcutaneous injection |
Other: Placebo
matching placebo administered via subcutaneous injection
|
Outcome Measures
Primary Outcome Measures
- Safety and tolerability of EXT608 - Adverse events [Day 0 to Day 28]
Monitoring of treatment-emergent Adverse Events
- Safety and tolerability of EXT608-clinical laboratory assessments [Day 0 to Day 28]
Frequency and severity of post-dose change from baseline in hematology, serum chemistry and urinalysis
- Safety and tolerability of EXT608- ECG PR interval [Day 0 to Day 28]
Frequency and severity of post-dose change from baseline of 12-lead ECG PR interval
- Safety and tolerability of EXT608- ECG QRS interval [Day 0 to Day 28]
Frequency and severity of post-dose change from baseline of 12-lead ECG QRS interval
- Safety and tolerability of EXT608- ECG RR interval [Day 0 to Day 28]
Frequency and severity of post-dose change from baseline of 12-lead ECG RR interval
- Safety and tolerability of EXT608- ECG QT interval [Day 0 to Day 28]
Frequency and severity of post-dose change from baseline of 12-lead ECG QT interval
- Number of participants with participants with treatment-related adverse events as assessed by CTCAE v4.0 - Blood pressure [Day 0 to Day 28]
Frequency and severity of post-dose change from baseline Blood pressure measurement
- Number of participants with participants with treatment-related adverse events as assessed by CTCAE v4.0 - Pulse rate [Day 0 to Day 28]
Frequency and severity of post-dose change from baseline Pulse rate measurement
- Number of participants with participants with treatment-related adverse events as assessed by CTCAE v4.0 - Respiratory rate [Day 0 to Day 28]
Frequency and severity of post-dose change from baseline Respiratory rate measurement
- Safety and tolerability of EXT608 - Physical exam [Day 0 to Day 28]
Physical exam based upon symptoms reported by participant
- Safety and tolerability of EXT608- injection site reactions [Day 0 to Day 28]
Percentage of participants with injection site reactions
Secondary Outcome Measures
- Single dose PK- AUC [Up to Day 3]
Area under the curve
- Single dose PK-Cmax [Up to Day 3]
Maximum observed concentration
- Single dose PK - Tmax [up to Day 3]
time to reach maximum observed plasma concentration
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female between 18 and 55 years of age.
-
Body mass index between 18.5 and 32 kilogram per square meter (kg/m2), inclusive, with a body weight greater than or equal to (>=) 45 kg.
-
In general good medical health with no clinically significant or relevant abnormalities,
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A clinical safety laboratory parameter of hemoglobin greater than (>) 11.7 gram per deciliter (g/dl) (females) or 13.1 g/dl (males) and less than (<) 16 g/dl (females) or 17.4 g/dl (males) or, if out of this range, deemed not clinically significant by the Investigator.
-
Total Se-Ca within laboratory normal limits.
-
Serum parathyroid hormone (PTH) concentration within normal laboratory limits.
Exclusion Criteria:
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Evidence of clinically significant (CS) neurologic, cardiovascular, pulmonary, hepatic, hematopoietic disease, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, serious allergy, allergic skin rash, or psychiatric disorder
-
History of drug abuse
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Currently using any medication (including over-the-counter [OTC], herbal or homeopathic preparations
-
Pregnant, nursing, or planning a pregnancy during the course of or within 3 months of completing this study
-
History of cancer or other malignancy, with the exception of basal cell carcinoma that has been in remission for at least 5 years
-
Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or a human immunodeficiency virus (HIV)
-
ALT and/or AST >1.5 the ULN
-
Increased baseline risk for osteosarcoma
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | PRA | Lenexa | Kansas | United States | 66219 |
Sponsors and Collaborators
- Extend Biosciences Inc.
- Integrated Medical Development
- National Institutes of Health (NIH)
- Pharmaceutical Research Associates
Investigators
- Study Director: Laura Hales, PhD, Extend Biosciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EXT608-101
- DK107231