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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05288543




Registration number
NCT05288543
Ethics application status
Date submitted
17/03/2022
Date registered
21/03/2022
Date last updated
7/04/2022

Titles & IDs
Public title
A Study of Orally Administered IPG7236 in Healthy Adult Participants
Scientific 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
Secondary ID [1] 0 0
IPG7236-A002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IPG7236- Single ascending dose
Treatment: Drugs - IPG7236- Multiple ascending dose
Other interventions - Placebo (Part A)

Experimental: Single Ascending Dose Phase - 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)

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

Placebo Comparator: Part A (Placebo) - Placebo tablets identical to IPG7236 tablets Dosage form: Tablet Route of Administration: Oral


Treatment: Drugs: IPG7236- Single ascending dose
Subjects will receive IPG7236 tablets orally once on Day 1 in a fasted state

Treatment: Drugs: IPG7236- Multiple ascending dose
Subjects will receive IPG7236 tablets orally once daily for 10 days from Day1 to Day 10 in a fasted state

Other interventions: 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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to 36 days
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
Up to 45 days
Secondary outcome [1] 0 0
To assess the pharmacokinetic (PK) parameters of IPG7236 after ascending single oral doses
Timepoint [1] 0 0
Up to 36 days
Secondary outcome [2] 0 0
To assess the pharmacokinetic (PK) parameters of IPG7236 after ascending single oral doses
Timepoint [2] 0 0
Up to 36 days
Secondary outcome [3] 0 0
To assess the pharmacokinetic (PK) parameters of IPG7236 after ascending multiple oral doses
Timepoint [3] 0 0
Up to 45 days
Secondary outcome [4] 0 0
To assess the pharmacokinetic (PK) parameters of IPG7236 after ascending multiple oral doses
Timepoint [4] 0 0
Up to 45 days
Secondary outcome [5] 0 0
To evaluate the effect of food on the PK of IPG7236
Timepoint [5] 0 0
Up to 45 days

Eligibility
Key inclusion criteria
1. Healthy adult male or female participants between 18 and 55 years of age (inclusive).

2. Body weight between 45 and 100 kg (inclusive) and body mass index (BMI) within 18~32
kg/m2 (inclusive).

Health status

3. 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).

4. A negative result on urine drug screen and a repeat negative result on Day -1
(amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine,
opiates).

5. 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.

6. Provide written informed consent prior to undertaking any study-related procedures.

7. Must not be under any administrative or legal supervision or under
institutionalization as per a regulatory or juridical order.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. 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.

2. Frequent severe headaches and/or migraines, recurrent nausea and/or vomiting (defined
as vomiting more than twice a month).

3. Made a blood or plasma donation of =500 ml within 1 month prior to the first dose.

4. 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.

5. Known hypersensitivity to any component of the IMP formulation.

6. History or presence of drug or alcohol abuse (defined as alcohol consumption of more
than 2 units per day on a regular basis).

7. 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

8. Excessive consumption of beverages containing xanthine bases (defined as more than 4
glasses per day).

9. 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.

10. Any consumption of grapefruit or products containing grapefruit within 5 days prior to
the first dose administration.

11. 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)

12. 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.

13. 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.

14. Any participant who cannot be contacted in the case of an emergency.

15. 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

16. 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).

17. Positive alcohol test at D-1.

18. Any participant in whom venous blood collection is difficult.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
11/04/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2022
Actual
Sample size
Target
86
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research Ltd - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Nanjing Immunophage Biotech Co., Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05288543
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Daisy Zhu
Address 0 0
Country 0 0
Phone 0 0
21 34782827&
Fax 0 0
Email 0 0
xyzhu@immunophage.com.cn
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05288543