A Study of Orally Administered IPG7236 in Healthy Adult Participants

NCT05288543 | Terminated Phase 1 DMC

• 1 other identifier: IPG7236-A002
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a phase 1, randomized, double-blind, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetic and food effect of orally administered IPG7236 in healthy adult participants.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• To assess the safety and tolerability of IPG7236 after ascending single oral doses through adverse events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events v5

  Up to 36 days

• To assess the safety and tolerability of IPG7236 after ascending multiple oral doses through adverse events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events v5

  Up to 45 days

Secondary Outcomes (5)

• To assess the pharmacokinetic (PK) parameters of IPG7236 after ascending single oral doses

  Up to 36 days

• To assess the pharmacokinetic (PK) parameters of IPG7236 after ascending single oral doses

  Up to 36 days

• To assess the pharmacokinetic (PK) parameters of IPG7236 after ascending multiple oral doses

  Up to 45 days

• To assess the pharmacokinetic (PK) parameters of IPG7236 after ascending multiple oral doses

  Up to 45 days

• To evaluate the effect of food on the PK of IPG7236

  Up to 45 days

Study Arms (3)

Single Ascending Dose Phase

EXPERIMENTAL

Drug: IPG7236 Dosage form: Tablet Route of Administration: Oral Dose level: Cohort 1 (25 mg), Cohort 2 (50 mg), Cohort 3 (100 mg), Cohort 4 (200 mg), Cohort 5 (300 mg), Cohort 6 (400 mg), Cohort 7 (500 mg) and Cohort 8 (600 mg)

Drug: IPG7236- Single ascending dose

Multiple Ascending Dose Phase

EXPERIMENTAL

Drug: IPG7236 Dosage form: Tablet Route of Administration: Oral Dose level: Cohort 1 (100 mg), Cohort 2 (300 mg) and Cohort 3 (500 mg)

Drug: IPG7236- Multiple ascending dose

Part A (Placebo)

PLACEBO COMPARATOR

Placebo tablets identical to IPG7236 tablets Dosage form: Tablet Route of Administration: Oral

Other: Placebo (Part A)

Interventions

IPG7236- Single ascending dose DRUG

Subjects will receive IPG7236 tablets orally once on Day 1 in a fasted state

Single Ascending Dose Phase

IPG7236- Multiple ascending dose DRUG

Subjects will receive IPG7236 tablets orally once daily for 10 days from Day1 to Day 10 in a fasted state

Multiple Ascending Dose Phase

Placebo (Part A) OTHER

Subjects will receive IPG7236 tablets orally once on Day 1 (Part A) or once daily for 10 days from Day1 to Day 10 (Part B) in a fasted state

Part A (Placebo)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male or female participants between 18 and 55 years of age (inclusive).
• Body weight between 45 and 100 kg (inclusive) and body mass index (BMI) within 18\~32 kg/m2 (inclusive).
• Health status
• In good health as determined by screening tests. Good health is defined as having no clinically relevant abnormalities identified by a detailed medical history, full physical examination (including measurement of blood pressure and pulse rate), 12-lead Electrocardiograph (ECG), and clinical laboratory tests.
• Vital signs (measured after resting for 5 minutes semi-supine position) within a normal range of the clinical site,, or outside the normal range and not considered clinically significant by the Investigator.
• Standard 12-lead Electrocardiograph (ECG) parameters (recorded after resting for 5 minutes in semi-supine position) in the following ranges; QTc (Fridericia algorithm recommended) ≤ 450 ms for males and 470 ms for females, and normal ECG tracing, or abnormal ECG tracing not considered clinically relevant by the Investigator.
• Laboratory parameters demonstrating no clinically significant abnormalities, as determined by the Investigator. Total bilirubin outside the normal range may be acceptable if total bilirubin does not exceed 1.5x ULN with normal conjugated bilirubin (with the exception of a patient with documented Gilbert syndrome).
• A negative result on urine drug screen and a repeat negative result on Day -1 (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
• Female participants must not be pregnant or breastfeeding and must use an effective contraception method with the exception of participants who have undergone sterilization more than 3 months prior to screening or who are postmenopausal.
• A woman of childbearing potential (WOCBP) must undergo pregnancy testing prior to the first dose of the study drug. The participant must be excluded from the study if the serum pregnancy test is positive.
• A postmenopausal state is defined as 12 months of amenorrhea without an alternative medical cause. In the absence of 12 months of amenorrhea, menopause may be confirmed by follicle stimulating hormone (FSH) measurement (\> 40 IU/L or mIU/mL).
• Females on HRT (Hormonal Replacement therapy), where menopausal status is indeterminate, will be required to use a non-estrogen hormonal contraceptive method if participants wish to continue their HRT during the study. Participants must otherwise discontinue HRT to allow for confirmation of postmenopausal status prior to enrollment in the study.
• Provide written informed consent prior to undertaking any study-related procedures.
• Must not be under any administrative or legal supervision or under institutionalization as per a regulatory or juridical order.

You may not qualify if:

• Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, musculoskeletal, rheumatological, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
• Frequent severe headaches and/or migraines, recurrent nausea and/or vomiting (defined as vomiting more than twice a month).
• Made a blood or plasma donation of ≥500 ml within 1 month prior to the first dose.
• Demonstrated clinically significant (required intervention, e.g., emergency room visit, epinephrine administration) allergic reactions, which in the opinion of the Investigator, would interfere with the volunteer's ability to participate in the trial.
• Known hypersensitivity to any component of the IMP formulation.
• History or presence of drug or alcohol abuse (defined as alcohol consumption of more than 2 units per day on a regular basis).
• Regular smoking (defined as more than 5 cigarettes or equivalent per week), or unable to stop smoking during the study. Occasional smokers may be enrolled but need to abstain during admission to the site
• Excessive consumption of beverages containing xanthine bases (defined as more than 4 glasses per day).
• Any medication, including St John's Wort, within 14 days prior to administration of the first dose or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception, menopausal hormone replacement therapy, or occasional paracetamol at doses up to 2g/day.
• Any consumption of grapefruit or products containing grapefruit within 5 days prior to the first dose administration.
• Any vaccination in the 2 weeks prior to administration of the first dose (Covid19 vaccination included, and planned COVID19 vaccinations, including booster shots, during the study or for 2 weeks after the last dose of the study drug)
• Any participant who, in the judgment of the Investigator, is likely to be non-compliant during the study, or to be unable to cooperate due to language problems or poor mental development.
• Any participant who enrolled in or participated in any other clinical study involving an investigational medicinal product, or in any other type of medical research within 1 month or within 5 times the elimination half-life prior to administration of the first dose.
• Any participant who cannot be contacted in the case of an emergency.
• Any participant who is the Investigator or any subinvestigator, research assistant, pharmacist, study coordinator, or other staff thereof directly involved in conducting the study or any person dependent on (employees or immediate family members) the study site, the Investigator or the Sponsor.

Sponsors & Collaborators

• Nanjing Immunophage Biotech Co., Ltd: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (1)

Scientia Clinical Research Ltd

Randwick, New South Wales, 2031, Australia

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

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 17, 2022
• First Posted: March 21, 2022
• Study Start: April 7, 2022
• Primary Completion: March 31, 2023
• Study Completion: November 26, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

AU (1)