Evaluate IMG-007 in Healthy Participants

Sponsor

Inmagene Biopharmaceuticals (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05353972

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This first in human (FIH) study will evaluate the safety, tolerability, pharmacokinetics (PK)), and immunogenicity of a single ascending dose of IMG-007 in healthy participants.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: IMG-007 or placebo	Phase 1

Detailed Description

This study is a double-blind, randomized, placebo-controlled, sequential ascending, single dose escalating (SAD) study to assess the safety and PK profile of IMG-007 in healthy participants. The study is comprised of 3 phases: screening phase, treatment phase, and safety follow-up phase.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of IMG-007 in Healthy Participants

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 Single dose of IMG or placebo solution, intravenously administered	Drug: IMG-007 or placebo intravenously administered
Experimental: Cohort 2 Single dose of IMG or placebo solution, intravenously administered	Drug: IMG-007 or placebo intravenously administered
Experimental: Cohort 3 Single dose of IMG or placebo solution, intravenously administered	Drug: IMG-007 or placebo intravenously administered
Experimental: Cohort 4 Single dose of IMG or placebo solution, intravenously administered	Drug: IMG-007 or placebo intravenously administered
Experimental: Cohort 5 Single dose of IMG or placebo solution, intravenously administered	Drug: IMG-007 or placebo intravenously administered
Experimental: Cohort 6 Single dose of IMG or placebo solution, intravenously administered	Drug: IMG-007 or placebo intravenously administered
Experimental: Cohort 7 Single dose of IMG or placebo solution, intravenously administered	Drug: IMG-007 or placebo intravenously administered

Outcome Measures

Primary Outcome Measures

Incidence and severity of treatment-emergent adverse events (TEAEs) [Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;]
Incidence and severity of treatment-emergent adverse events (TEAEs)

Secondary Outcome Measures

Maximum observed concentration (Cmax) after infusion [Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;]
Maximum observed concentration (Cmax) after infusion
Time at which Cmax is observed after infusion (tmax) [Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;]
Time at which Cmax is observed after infusion (tmax)
Area under the concentration time curve from time 0 to last observation (AUC 0-t) [Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;]
Area under the concentration time curve from time 0 to last observation (AUC 0-t)
Area under the concentration time curve from time 0 to infinity (AUC0-inf) [Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;]
Area under the concentration time curve from time 0 to infinity (AUC0-inf)
Half-life t½ [Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;]
Half-life t½
Incidence of anti-drug antibody (ADA) after infusion [Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;]
Incidence of anti-drug antibody (ADA) after infusion

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Participants aged between 18 to 50 years (inclusive)
Body mass index (BMI) greater than or equal to 18.0 kg/m2 and less than 32 kg/m2 and a minimum body weight of 50 kg for males and 45 kg for females at both the Screening and Baseline visits.
Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study.

Exclusion Criteria:

History of disease of the central nervous system, cardiovascular system, kidney, liver, digestive system, respiratory system, or metabolic/endocrine system
History of immunological abnormality
History of severe immediate hypersensitivity reaction to OX40 antagonists or other monoclonal antibodies
History of anaphylaxis or significant reactions to foods, medications, or other allergens
Major surgery ≤4 weeks before Baseline visit.
History of malignancy or known current malignancy,
Participant has an active infection or history of infections
Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or antibody to Hepatitis B core antigen (HBcAb) with positive test for HBV DNA (>500 IU/ml) or hepatitis C antibodies (HCV) at Screening visit.
History of asthma
Having evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
Participants with positive testing for COVID-19 at the Baseline visit.
Participants with clinically significantly abnormal laboratory values, as determined by the Investigator or medically qualified designee, i
Clinically significant abnormal findings at Screening or Baseline visits
Systolic blood pressure below 100 mmHg, at any time points prior to IMP administration
Use of any prescription medication
Use of over-the-counter medication
History of, or current substance abuse considered significant
Use of more than 5 tobacco/nicotine-containing products
Average alcohol consumption of more than 14 units/week for females and 21 units/week for males
Receipt of an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) prior to Day 1 dosing.
Live (attenuated) vaccination within 8 weeks before Screening or plan to be vaccinated by live (attenuated) vaccine during the trial
COVID-19 vaccination, or influenza vaccination(inactivated), within 14 days prior or planning to receive COVID-19 vaccination or influenza vaccination(inactivated) within 14 days post IMP administration.
Donated or lost more than 500 mL of blood or plasma within 3 months of Screening or received blood products within 8 weeks of Screening.
Pregnant or lactating women.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Inmagene Biopharmaceuticals

Investigators

Principal Investigator: Peter Schrader, Linear

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Inmagene Biopharmaceuticals

ClinicalTrials.gov Identifier:

NCT05353972

Other Study ID Numbers:

IMG-007-101

First Posted:

Apr 29, 2022

Last Update Posted:

May 11, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of May 11, 2022