Status:
COMPLETED
A Phase 1 Study of EXT608 in Healthy Adults
Lead Sponsor:
Extend Biosciences Inc.
Collaborating Sponsors:
Integrated Medical Development
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Safety Issues
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 coh...
Detailed Description
This is a randomized, double-blind, first-in-human, placebo-controlled single ascending dose study to study the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EXT608 in heal...
Eligibility Criteria
Inclusion
- 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,
- 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 serum calcium (Se-Ca) within laboratory normal limits.
- Serum parathyroid hormone (PTH) concentration within normal laboratory limits.
Exclusion
- 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
- 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)
- Alanine transaminase (ALT) and/or aspartate transaminase (AST) \>1.5 the upper limit of normal (ULN)
- Increased baseline risk for osteosarcoma
Key Trial Info
Start Date :
July 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05408663
Start Date
July 21 2022
End Date
June 13 2023
Last Update
February 4 2025
Active Locations (1)
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1
PRA
Lenexa, Kansas, United States, 66219