A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of IBIO-600 in Overweight or Obese Adults

NCT07487376 | Recruiting Phase 1

• 1 other identifier: IBIO-600-CT001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn which dose of study drug IBIO-600 has the right balance of safety, tolerability and impact on body composition in overweight and obese adult participants.

Conditions

Overweight , Obesity

Keywords

iBio; Overweight; Obesity; Phase I; IBIO-600; Myostatin

Outcome Measures

Primary Outcomes (1)

• Assessment of the safety and tolerability of a single dose of IBIO-600

  Incidence, severity, and relationship to study treatment of TEAEs and SAEs, as determined by clinical laboratory evaluations, vital signs, physical examinations, and ECGs.

  From Day 1 through Day 252 (end of study).

Secondary Outcomes (10)

• Pharmacokinetics of a single dose of IBIO-600

  Baseline up to Week 36

• Pharmacokinetics of a single dose of IBIO-600

  Baseline up to Week 36

• Pharmacokinetics of a single dose of IBIO-600

  Baseline to the last measurable concentration (AUC0-last)

• Pharmacokinetics of a single dose of IBIO-600

  Baseline to infinity (AUC0-inf)

• Pharmacokinetics of a single dose if IBIO-600

  Baseline up to Week 36

Study Arms (5)

IBIO-600 (Cohort 1)

EXPERIMENTAL

Drug: IBIO-600

IBIO-600 (Cohort 2)

EXPERIMENTAL

Drug: IBIO-600

IBIO-600 (Cohort 3)

EXPERIMENTAL

Drug: IBIO-600

IBIO-600 (Cohort 4)

EXPERIMENTAL

Drug: IBIO-600

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

IBIO-600 DRUG

IBIO-600 Subcutaneous injection

IBIO-600 (Cohort 1); IBIO-600 (Cohort 2); IBIO-600 (Cohort 3); IBIO-600 (Cohort 4)

Placebo DRUG

Matching placebo; subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 65 years of age
• In good general health, with no significant medical history
• BMI between ≥ 27.0 and ≤ 34.90 kg/m2
• History of self-reported stable body weight (defined as change of no more or less than ± 5%) within 90 days of Screening.
• Willingness to refrain from any reconstructive and/or cosmetic surgery and/or non-invasive cosmetic procedure that may affect body weight during the study
• Must be fully ambulatory without any chronic orthopedic diseases or reliance on crutches, walkers, or a wheelchair that may preclude normal activity.
• Be a nonsmoker/nonvaper and must not have used any nicotine or synthetic type products within 1 month prior to randomization.
• Must not be pregnant or breastfeeding
• Woman of childbearing potential (WOCBP) or fertile man agrees to use an acceptable method of contraception from the start of Screening until study completion, or for a minimum of 9 months following the last dose of IP, whichever period is longer.

You may not qualify if:

• An underlying physical or psychological medical conditions that, in the opinion of the PI or medical designee, would make the participant unlikely to comply with the protocol or complete the study per protocol.
• History or active diagnosis of diabetes (Type 1 or 2).
• History of insulinoma or recurrent hypoglycemia (≥ 3 episodes in past 3 months).
• History or presence of clinically significant muscle disease
• History of or active cardiovascular disease including clinically significant arrhythmias, Class I-IV heart failure, coronary artery disease, thromboembolic event, or pulmonary hypertension.
• Clinically significant laboratory abnormalities that would preclude participation in the study.
• History of malignancy, except for non-melanoma skin cancer excised \> 2 years ago or cervical intraepithelial neoplasia successfully treated \> 5 years prior to randomization.
• History or presence of any condition associated with significant immunosuppression.
• History of substance abuse or dependency, or recreational IV drug use within the past 5 years (self-reported).

Sponsors & Collaborators

• iBio, Inc.: lead

Study Sites (1)

Veritus Research

Bayswater, Victoria, 3153, Australia

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cory Schwartz, PhD

  iBio, Inc.

  STUDY DIRECTOR

Central Study Contacts

Cory Schwartz, PhD

CONTACT

979-446-0027; IBIO-600-CT001@ibioinc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 23, 2026
• Study Start: May 24, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)