A Phase 1 Study of EXT608 in Healthy Adults

NCT05408663 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: EXT608-101R44DK107231
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Safety Issues

Outcome Measures

Primary Outcomes (3)

• Characterize the Safety and Tolerability of EXT608

  Incidence, nature and severity of adverse events (AEs) and withdrawals due to Treatment-Emergent Adverse Events (TEAEs)

  Day 0 to Day 28

• Characterize the Safety and Tolerability of EXT608

  Frequency and severity of post-dose change from baseline of hematology, serum chemistry, urinalysis, electrocardiogram (ECG), vital signs and physical examination findings

  Day 0 - Day 28

• Characterize the Safety and Tolerability of EXT608

  Percentage of participants with injection or infusion site reactions - edema

  Day 0 - Day 28

Secondary Outcomes (3)

• Single Dose Pharmacokinetics (PK) - Area Under the Curve (AUC)

  Day 0 to Day 7

• Single Dose PK - Cmax

  0-24 hr

• Single Dose PK - Tmax

  Day 0 to Day 7

Study Arms (2)

Experimental- EXT608

EXPERIMENTAL

Up to 6 sequential dose escalation cohorts will receive a single dose of EXT608 administered as a subcutaneous injection

Drug: EXT608

Placebo comparator

PLACEBO COMPARATOR

Up to 6 participants will receive matching placebo administered as a subcutaneous injection

Other: Placebo

Interventions

EXT608 DRUG

EXT608 is an investigational drug administered via subcutaneous injection

Also known as: test drug

Experimental- EXT608

Placebo OTHER

matching placebo administered via subcutaneous injection

Placebo comparator

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Extend Biosciences Inc.: lead
• Integrated Medical Development: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Pharmaceutical Research Associates: collaborator

Study Sites (1)

PRA

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Interventions

Drug Evaluation

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Results Point of Contact

• Title: Laura Hales PhD
• Organization: Extend Biosciences

lhales@extendbio.com

(732) 599-8581

Study Officials

• Laura Hales, PhD

  Extend Biosciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, investigator)
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single ascending dose with up to 6 sequential dose escalation cohorts. Participants will be randomized to either study intervention (EXT608) or placebo

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 7, 2022
• Study Start: July 21, 2022
• Primary Completion: June 13, 2023
• Study Completion: June 13, 2023
• Last Updated: February 4, 2025
• Results First Posted: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)