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

May 27, 2026 updated by: iBio, Inc.

A Phase I, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBIO-600 in Overweight or Obese Adult Participants (IBIO-600-CT001).

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is a single ascending dose study, with participants monitored for 9 months after administration.

This clinical trial will seek to address the following:

  • Which dose of the study drug is most effective.
  • How safe the study drug is and how well participants tolerate it.
  • How much of the study drug can be found in blood (pharmacokinetics).
  • How the study drug affects the body (pharmacodynamics).
  • How the body's immune system responds to the study drug (immunogenicity).
  • How the body's composition and physical function may change over the course of the study.

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
Matching placebo; subcutaneous injection
Experimental: IBIO-600 (Cohort 1)
Drug: IBIO-600
IBIO-600 Subcutaneous injection
Experimental: IBIO-600 (Cohort 2)
Drug: IBIO-600
IBIO-600 Subcutaneous injection
Experimental: IBIO-600 (Cohort 3)
Drug: IBIO-600
IBIO-600 Subcutaneous injection
Experimental: IBIO-600 (Cohort 4)
Drug: IBIO-600
IBIO-600 Subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the safety and tolerability of a single dose of IBIO-600
Time Frame: From Day 1 through Day 252 (end of study).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of a single dose of IBIO-600
Time Frame: Baseline up to Week 36
Maximum observed serum concentration (Cmax)
Baseline up to Week 36
Pharmacokinetics of a single dose of IBIO-600
Time Frame: Baseline up to Week 36
Time to maximum concentration (Tmax)
Baseline up to Week 36
Pharmacokinetics of a single dose of IBIO-600
Time Frame: Baseline to the last measurable concentration (AUC0-last)
Area under the curve (AUC)
Baseline to the last measurable concentration (AUC0-last)
Pharmacokinetics of a single dose of IBIO-600
Time Frame: Baseline to infinity (AUC0-inf)
AUC
Baseline to infinity (AUC0-inf)
Pharmacokinetics of a single dose if IBIO-600
Time Frame: Baseline up to Week 36
t½: half-life
Baseline up to Week 36
Pharmacokinetics of a single dose of IBIO-600
Time Frame: Baseline through Week 36
Apparent total body clearance (CL/F)
Baseline through Week 36
Pharmacokinetics of a single dose of IBIO-600
Time Frame: Baseline up to Week 36
Apparent volume of distribution (Vz/F)
Baseline up to Week 36
Pharmacodynamics (PD) of a single dose of IBIO-600
Time Frame: Baseline through Week 36
Change in circulating concentrations of total GDF8
Baseline through Week 36
Pharmacodynamics of a single dose of IBIO-600
Time Frame: Baseline up to Week 36
Change in circulating concentrations of total GDF11
Baseline up to Week 36
Pharmacodynamics of a single dose of IBIO-600
Time Frame: Baseline up to Week 36
Change in lipid panel tests
Baseline up to Week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iBio, Inc.

Investigators

  • Study Director: Cory Schwartz, PhD, iBio, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBIO-600-CT001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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