Atopic DermatitisPhase 1NCT05288543
A Study of Orally Administered IPG7236 in Healthy Adult Participants
A Phase 1 study testing IPG7236- Single ascending dose and IPG7236- Multiple ascending dose in people with Atopic Dermatitis, run by Nanjing Immunophage Biotech Co., Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- IPG7236- Single ascending dose and IPG7236- Multiple ascending dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteAustralia
- Study dates
- 7 Apr 2022to 26 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
- Biological status
- Positive result on any of the following tests: hepatitis B surface antigen (HbsAg), hepatitis B core antibodies (HbcAb), anti-hepatitis C virus antibodies (anti-HCV), anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti-HIV2 Ab).
- Positive alcohol test at D-1.
- Any participant in whom venous blood collection is difficult.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Scientia Clinical Research Ltd
Randwick, New South Wales, 2031
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Food Effect of Orally Administered IPG7236 in Healthy Adult Participants
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.
Read the detailed description
The study consists of two parts
Part A (Single ascending dose): There are total 8 Single Ascending Dose cohorts.
Dose levels are as follows Cohort 1: 25 mg of IPG7236 or placebo as per the randomization code, Cohort 2: 50 mg of IPG7236 or placebo as per the randomization code Cohort 3: 100 mg of IPG7236 or placebo as per the randomization code Cohort 4: 200 mg of IPG7236 or placebo as per the randomization code Cohort 5: 300 mg of IPG7236 or placebo as per the randomization code Cohort 6: 400 mg of IPG7236 or placebo as per the randomization code Cohort 7: 500 mg of IPG7236 or placebo as per the randomization code Cohort 8: 600 mg of IPG7236 or placebo as per the randomization code In Cohort 1 total of 6 subjects enrolled. The 4 subjects will receive IPG7236 and 2 subjects will receive the placebo as per the randomization code.
In Cohort 2 to Cohort 8, 6 subjects will receive IPG7236 and 2 subjects will receive the placebo as per the randomization code.
Part B (Multiple ascending dose): There are total 3 Multiple ascending dose cohorts.
Dose levels are as follows Cohort 1: 100 mg of IPG7236 or placebo as per the randomization code Cohort 2: 300 mg of IPG7236 or placebo as per the randomization code Cohort 3: 500 mg of IPG7236 or placebo as per the randomization code Total of 8 subjects per cohort, 6 subjects will receive IPG7236 and 2 subjects will receive placebo per the randomization code The Multiple Ascending Dose phase of Cohort 1, Cohort 2 and Cohort 3 will commence based on the safety and tolerability data obtained from Single Ascending Dose phase of Cohort 4, Cohort 6 and Cohort 8.
- Conditions
- Atopic Dermatitis
- Being tested
- IPG7236- Single ascending dose, IPG7236- Multiple ascending dose, Placebo (Part A)
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPG7236- Single ascending doseDrug
Subjects will receive IPG7236 tablets orally once on Day 1 in a fasted state
IPG7236- Multiple ascending doseDrug
Subjects will receive IPG7236 tablets orally once daily for 10 days from Day1 to Day 10 in a fasted state
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: IPG7236- Multiple ascending dose |
| Part A (Placebo) | Placebo comparator | Placebo tablets identical to IPG7236 tablets Dosage form: Tablet Route of Administration: Oral Receives: Other: Placebo (Part A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to 45 days
Secondary outcomes (5)
To assess the pharmacokinetic (PK) parameters of IPG7236 after ascending single oral doses
Plasma PK parameters: Cmax (maximum plasma concentration)
Measured: Up to 36 days
To assess the pharmacokinetic (PK) parameters of IPG7236 after ascending single oral doses
Plasma PK parameters: Tmax (time to Cmax)
Measured: Up to 36 days
To assess the pharmacokinetic (PK) parameters of IPG7236 after ascending multiple oral doses
Plasma PK parameters: Css,max (maximum plasma concentration at steady state)
Measured: Up to 45 days
To assess the pharmacokinetic (PK) parameters of IPG7236 after ascending multiple oral doses
Plasma PK parameters: CTss,max (time to maximum plasma concentration at steady state)
Measured: Up to 45 days
To evaluate the effect of food on the PK of IPG7236
Pharmacokinetics parameters using Cmax (maximum plasma concentration)
Measured: Up to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start7 Apr 2022
- Primary completion31 Mar 2023
- Study completion26 Nov 2025
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Immunophage Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288543
- Sponsor's protocol ID
- IPG7236-A002
- Status last verified
- Dec 2025
- First submitted
- 17 Mar 2022
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Food Effect of Orally Administered IPG7236 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT05288543
- Acronym / sponsor ID
- IPG7236-A002
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Nanjing Immunophage Biotech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study consists of two parts
Part A (Single ascending dose): There are total 8 Single Ascending Dose cohorts.
Dose levels are as follows Cohort 1: 25 mg of IPG7236 or placebo as per the randomization code, Cohort 2: 50 mg of IPG7236 or placebo as per the randomization code Cohort 3: 100 mg of IPG7236 or placebo as per the randomization code Cohort 4: 200 mg of IPG7236 or placebo as per the randomization code Cohort 5: 300 mg of IPG7236 or placebo as per the randomization code Cohort 6: 400 mg of IPG7236 or placebo as per the randomization code Cohort 7: 500 mg of IPG7236 or placebo as per the randomization code Cohort 8: 600 mg of IPG7236 or placebo as per the randomization code In Cohort 1 total of 6 subjects enrolled. The 4 subjects will receive IPG7236 and 2 subjects will receive the placebo as per the randomization code.
In Cohort 2 to Cohort 8, 6 subjects will receive IPG7236 and 2 subjects will receive the placebo as per the randomization code.
Part B (Multiple ascending dose): There are total 3 Multiple ascending dose cohorts.
Dose levels are as follows Cohort 1: 100 mg of IPG7236 or placebo as per the randomization code Cohort 2: 300 mg of IPG7236 or placebo as per the randomization code Cohort 3: 500 mg of IPG7236 or placebo as per the randomization code Total of 8 subjects per cohort, 6 subjects will receive IPG7236 and 2 subjects will receive placebo per the randomization code The Multiple Ascending Dose phase of Cohort 1, Cohort 2 and Cohort 3 will commence based on the safety and tolerability data obtained from Single Ascending Dose phase of Cohort 4, Cohort 6 and Cohort 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose Phase | Experimental | Drug: IPG7236- Single ascending doseDrug: 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) |
| Multiple Ascending Dose Phase | Experimental | Drug: IPG7236- Multiple ascending doseDrug: IPG7236 Dosage form: Tablet Route of Administration: Oral Dose level: Cohort 1 (100 mg), Cohort 2 (300 mg) and Cohort 3 (500 mg) |
| Part A (Placebo) | Placebo comparator | Other: Placebo (Part A)Placebo tablets identical to IPG7236 tablets Dosage form: Tablet Route of Administration: Oral |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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.
- A negative result on urine drug screen and a repeat negative result on Day -1 (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPG7236- Single ascending doseSubjects will receive IPG7236 tablets orally once on Day 1 in a fasted state | Drug | Single Ascending Dose Phase |
| IPG7236- Multiple ascending doseSubjects will receive IPG7236 tablets orally once daily for 10 days from Day1 to Day 10 in a fasted state | Drug | Multiple Ascending Dose Phase |
| Placebo (Part A)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 | Other | Part A (Placebo) |
Primary outcome
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
Time frame: 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
Time frame: Up to 45 days
5 secondary outcomes
To assess the pharmacokinetic (PK) parameters of IPG7236 after ascending single oral doses
Time frame: Up to 36 days
To assess the pharmacokinetic (PK) parameters of IPG7236 after ascending single oral doses
Time frame: Up to 36 days
To assess the pharmacokinetic (PK) parameters of IPG7236 after ascending multiple oral doses
Time frame: Up to 45 days
To assess the pharmacokinetic (PK) parameters of IPG7236 after ascending multiple oral doses
Time frame: Up to 45 days
To evaluate the effect of food on the PK of IPG7236
Time frame: Up to 45 days
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IPG7236- Single ascending dose and IPG7236- Multiple ascending dose in people with Atopic Dermatitis, run by Nanjing Immunophage Biotech Co., Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Up to 36 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.