A Phase 1 Study of EXT608 in Healthy Adults

NCT ID: NCT05408663

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-21
• Study Completion Date: 2023-06-13

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.

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 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 Adverse Events (AEs) at the discretion of the Investigator

Conditions

Safety Issues

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental- EXT608

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

Group Type: EXPERIMENTAL

EXT608

Intervention Type: DRUG

EXT608 is an investigational drug administered via subcutaneous injection

Placebo comparator

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

matching placebo administered via subcutaneous injection

Interventions

EXT608

EXT608 is an investigational drug administered via subcutaneous injection

Intervention Type: DRUG

Placebo

matching placebo administered via subcutaneous injection

Intervention Type: OTHER

Other Intervention Names

test drug

Eligibility Criteria

Inclusion Criteria

1. Male or female between 18 and 55 years of age.

2. 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.

3. In general good medical health with no clinically significant or relevant abnormalities,

4. 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.

5. Total serum calcium (Se-Ca) within laboratory normal limits.

6. Serum parathyroid hormone (PTH) concentration within normal laboratory limits.

Exclusion Criteria

1. 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

2. History of drug abuse

3. Currently using any medication including over-the-counter (OTC), herbal or homeopathic preparations

4. Pregnant, nursing, or planning a pregnancy during the course of or within 3 months of completing this study

5. History of cancer or other malignancy, with the exception of basal cell carcinoma that has been in remission for at least 5 years

6. Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or a human immunodeficiency virus (HIV)

7. Alanine transaminase (ALT) and/or aspartate transaminase (AST) >1.5 the upper limit of normal (ULN)

8. Increased baseline risk for osteosarcoma

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Integrated Medical Development

INDUSTRY

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Pharmaceutical Research Associates

OTHER

Sponsor Role: collaborator

Extend Biosciences Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Hales, PhD

Role: STUDY_DIRECTOR

Extend Biosciences

Locations

PRA

Lenexa, Kansas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R44DK107231

Identifier Type: NIH

Identifier Source: secondary_id

View Link

EXT608-101

Identifier Type: -

Identifier Source: org_study_id