Study to Evaluate IMG-004 in Healthy Participants

NCT05349097 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: IMG-004-101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 1, Randomized, Double-blind, Placebo-controlled Study of Orally Administered IMG-004 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Dose(s) and an Open-Label Study of Single Oral Dose of IMG-004 to Evaluate the Food Effect in Healthy Participants

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• Safety of IMG-004

  Incidence and severity of AEs, including clinically relevant findings from vital signs, physical examination, laboratory tests, and 12-lead ECG

  SAD cohort from signing ICF up to Day 15; MAD cohort: from signing ICF to Day24

Secondary Outcomes (1)

• PK parameters of IMG-004

  SAD cohort from day 1 to day 8, MAD cohort from day 1 to day 17, FE cohort from day 1 to day 8

Study Arms (17)

SAD cohort 1 active treatment

EXPERIMENTAL

30mg

Drug: SAD IMG-004 30mg

SAD cohort 2 active treatment

EXPERIMENTAL

100mg.

Drug: SAD IMG-004 100mg

SAD cohort 3 active treatment

EXPERIMENTAL

200mg

Drug: SAD IMG-004 200mg

SAD cohort 4 active treatment

EXPERIMENTAL

400mg.

Drug: SAD IMG-004 400mg

SAD cohort 5 active treatment

EXPERIMENTAL

600mg.

Drug: SAD IMG-004 600mg

SAD cohort 1 placebo

PLACEBO COMPARATOR

30mg

Drug: SAD Placebo 30mg

SAD cohort 2 placebo

PLACEBO COMPARATOR

100mg.

Drug: SAD Placebo 100mg

SAD cohort 3 placebo

PLACEBO COMPARATOR

200mg.

Drug: SAD Placebo 200mg

SAD cohort 4 placebo

PLACEBO COMPARATOR

400mg.

Drug: SAD Placebo 400mg

SAD cohort 5 placebo

PLACEBO COMPARATOR

600mg.

Drug: SAD Placebo 600mg

MAD cohort 1 active treatment

EXPERIMENTAL

50mg

Drug: MAD IMG-004 50mg

MAD cohort 1 placebo

PLACEBO COMPARATOR

50mg

Drug: MAD Placebo 50mg

MAD cohort 2 active treatment

EXPERIMENTAL

150mg

Drug: MAD IMG-004 150mg

MAD cohort 2 placebo

PLACEBO COMPARATOR

150mg

Drug: MAD Placebo 150mg

MAD cohort 3 active treatment

EXPERIMENTAL

300mg

Drug: MAD IMG-004 300mg

MAD cohort 3 placebo

PLACEBO COMPARATOR

300mg

Drug: MAD Placebo 300mg

Food Effect cohort

EXPERIMENTAL

150mg

Drug: FE IMG-004 150mg

Interventions

SAD IMG-004 30mg DRUG

Each participant will be randomized to receive a single oral dose of 30mg IMG-004

SAD cohort 1 active treatment

SAD IMG-004 100mg DRUG

Each participant will be randomized to receive a single oral dose of 100mg IMG-004

SAD cohort 2 active treatment

SAD IMG-004 200mg DRUG

Each participant will be randomized to receive a single oral dose of 200mg IMG-004

SAD cohort 3 active treatment

SAD IMG-004 400mg DRUG

Each participant will be randomized to receive a single oral dose of 400mg IMG-004

SAD cohort 4 active treatment

SAD IMG-004 600mg DRUG

Each participant will be randomized to receive a single oral dose of 600mg IMG-004

SAD cohort 5 active treatment

SAD Placebo 30mg DRUG

Each participant will be randomized to receive a single oral dose of 30mg matching placebo

SAD cohort 1 placebo

SAD Placebo 100mg DRUG

Each participant will be randomized to receive a single oral dose of 100mg matching placebo

SAD cohort 2 placebo

SAD Placebo 200mg DRUG

Each participant will be randomized to receive a single oral dose of 200mg matching placebo

SAD cohort 3 placebo

SAD Placebo 400mg DRUG

Each participant will be randomized to receive a single oral dose of 400mg matching placebo

SAD cohort 4 placebo

SAD Placebo 600mg DRUG

Each participant will be randomized to receive a single oral dose of 600mg matching placebo

SAD cohort 5 placebo

MAD IMG-004 50mg DRUG

Each participant will be randomized to receive daily oral dose of 50mg IMG-004 for 10 days

MAD cohort 1 active treatment

MAD Placebo 50mg DRUG

Each participant will be randomized to receive daily oral dose of 50mg matching placebo for 10 days

MAD cohort 1 placebo

MAD IMG-004 150mg DRUG

Each participant will be randomized to receive daily oral dose of 150mg IMG-004 for 10 days

MAD cohort 2 active treatment

MAD Placebo 150mg DRUG

Each participant will be randomized to receive daily oral dose of 150mg matching placebo for 10 days

MAD cohort 2 placebo

MAD IMG-004 300mg DRUG

Each participant will be randomized to receive daily oral dose of 300mg IMG-004 for 10 days

MAD cohort 3 active treatment

MAD Placebo 300mg DRUG

Each participant will be randomized to receive daily oral dose of 300mg matching placebo for 10 days

MAD cohort 3 placebo

FE IMG-004 150mg DRUG

A single dose of IMG-004 at 150 mg dose level will be administered to the participants in fed and fasted states

Food Effect cohort

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult males and/or females, 18 to 60 years of age (inclusive) at the date of signed consent form.
• Body mass index (BMI) greater than or equal to 18.5 and less than 32 (kg/m2) and a minimum body weight of 45 kg.
• Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study.
• Male participants must agree to practice true abstinence; be surgically sterilized (performed at least 6 months prior and documented to no longer produce sperm - verbal confirmation through medical history review acceptable); or agree to use a condom plus ensure use of effective contraception by their female partner of childbearing potential (ie, established use of hormonal contraception - started at least 30 days before Day 1; or placement or an intrauterine device or intrauterine system, diaphragm with spermicide or cervical sponge with spermicide) from screening and for at least 30 days after dosing and refrain from donating sperm during this period. Contraception requirements do not apply for participants in an exclusively same-sex relationship or if their female partner is of non-childbearing potential. Males with pregnant partners may participate if they agree to use a barrier method of contraception.
• Female participants of non-childbearing potential, defined as surgically sterile (hysterectomy, bilateral salpingectomy, bilateral tubal ligation or bilateral oophorectomy, verbal confirmation through medical Confidential Page 17 of 75 history review acceptable) or postmenopausal (no menses for 12 months and confirmed by follicle-stimulating hormone (FSH) level ≥ 40 mIU/mL).

You may not qualify if:

• History of disease of the central nervous system, cardiovascular system, kidney, liver, digestive system, respiratory system, or metabolic/endocrine system, or other disease that in the opinion of the Investigator (or medically qualified designee) may make participation unsafe for the participant or interfere with trial evaluations or otherwise considered clinically significant.
• History of immunological abnormality (eg, primary or secondary immune suppression) that in the opinion of the Investigator (or medically qualified designee) may make participation unsafe for the participant or interfere with trial evaluations or otherwise considered clinically significant.
• History of severe immediate hypersensitivity reaction to BTK inhibitors, defined as non-cutaneous hypersensitivity reaction, requiring parenteral (IM/IV) therapy.
• Major surgery ≤ 4 weeks before Baseline visit. Participants must have also fully recovered from any surgery (major or minor) and/or its complications before initiating study treatment.
• History of malignancy or known current malignancy, except for adequately treated basal cell or squamous cell carcinoma of the skin.
• Participants who, in the Investigator's judgement, are perceived as having an increased risk of bleeding, eg, history of hemorrhagic disorders, clinical relevant petechial bleeding, occult blood in feces, hematuria in repeated urine tests(unless attributed to menstruation), trauma or surgery within the last month, planned surgery during trial participation, history of arteriovenous malformation or aneurysm, history of gastroduodenal ulcer disease or gastrointestinal hemorrhage, history of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intraarticular bleeding, use of drugs that may interfere with hemostasis during trial conduct (eg, acetylic salicylic acid or other non-steroidal anti-inflammatory drugs)
• Participant has an active infection or history of infections as follows:
• Acute infection requiring treatment with oral antibiotics, anti-virals, anti-parasitics, anti-protozoal, or anti-fungals within 14 days before the Baseline visit.
• A serious infection, defined as requiring hospitalization or intravenous anti-microbial therapy within 2 months prior to Baseline visit.
• A history of opportunistic, recurrent, or chronic 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.
• Having evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by the following:
• Positive Interferon Gamma Release Assay (IGRA) (with one of the following acceptable assays: QuantiFERON(R)-TB Gold (QFT-G) test, T-SPOT TB, QuantiFERON-TB Gold In-Tube test (QFT-GIT)) performed during Screening or within 3 months prior to Day 1. OR
• History of either untreated or inadequately treated latent or active TB infection.
• Participants with positive testing for COVID-19 at the Baseline visit.

Sponsors & Collaborators

• Inmagene LLC: lead

Study Sites (1)

Labcorp Cru

Daytona Beach, Florida, 32117-5116, United States

Location

Study Design

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

Study Record Dates

• First Submitted: April 17, 2022
• First Posted: April 27, 2022
• Study Start: August 8, 2022
• Primary Completion: May 2, 2024
• Study Completion: May 2, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

US (1)