Health TrialsbyHealthPanel

A Study of Single and Multiple Ascending Doses of H021 in Healthy Participants

ConditionUlcerative Colitis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorJiangsu Carephar Pharmaceutical Co., Ltd.

About this trial

The primary purpose of this study is to evaluate the safety and tolerability of H021 tablets following oral administration of single and multiple ascending doses in healthy participants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), greater than and equal to (>=) 18 and less than and equal to (<=) 55 years of age, with body mass index (BMI) greater than (>)18.5 and less than (<) 32.0 kilograms per square meter (kg/m²).

the absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.

the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.

post-menopausal (spontaneous amenorrhea for at least 12 months prior to dosing) with confirmation by documented follicle-stimulating hormone (FSH) levels >=40 milli-international units per milliliter (mIU/mL); or

Disqualifiers

Any clinically significant abnormal finding at physical examination.

Clinically significant abnormal laboratory test results including biochemistry, hematology, urinalysis, and coagulation results, or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody, or QuantiFERON®-TB test at screening.

Positive pregnancy test or lactating female participant.

Positive urine drug screen, urine cotinine test, or alcohol breath test at screening or Day -1.

Trial design

Design model

Parallel

Treatments tested in this trial

  • H021

    Drug

    H021 oral tablet.

  • H021 Placebo

    Drug

    H021 placebo oral tablet.

Treatment groups

64 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: SAD Cohort 1: H021 6.25 milligrams (mg)Experimental treatment 1 intervention
Group B: SAD Cohort 2: H021 12.5 mgExperimental treatment 1 intervention
Group C: SAD Cohort 3: H021 25 mgExperimental treatment 1 intervention
Group D: SAD Cohort 4: H021 50 mgExperimental treatment 1 intervention
Group E: SAD Cohort 5: H021 100 mgExperimental treatment 1 intervention
Group F: MAD Cohort 6: H021 12.5 mgExperimental treatment 1 intervention
Group G: MAD Cohort 7: H021 25 mgExperimental treatment 1 intervention
Group H: MAD Cohort 8: H021 50 mgExperimental treatment 1 intervention
Group I: SAD-H021 PlaceboPlacebo comparator 1 intervention
Group J: MAD-H021 PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Adverse Events (AEs)

An AE is defined as any untoward medical occurrence in a participant or clinical trial participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Any clinically significant changes in vital signs, electrocardiogram (ECG) measurement, physical examination and clinical laboratory parameters will be recorded as AE.

Time frame
Up to final follow-up (SAD Part: up to 8 days: MAD Part: up to 14 days)

Secondary outcomes

1

SAD Part: Area under the concentration-time curve from time zero until the last observed concentration (AUC0-t) of H021

AUC0-t is an area under the concentration-time curve from time zero (pre-dose) to time of last observed concentration.

Time frame
pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
2

SAD Part: Area under the concentration-time curve from time zero to infinity (AUC0-infinity) of H021

AUC0-infinity is an area under the concentration-time curve from time zero to infinity (extrapolated).

Time frame
pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
3

SAD Part: Maximal observed concentration (Cmax) of H021

Cmax is a measure of the maximum amount of drug in the plasma after the dose was given.

Time frame
pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
4

SAD Part: Time to Reach Cmax (Tmax) of H021

Tmax is a measure of the time to reach the maximum concentration in the plasma after the dose was given.

Time frame
pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose

Other outcomes

1

MAD Part: Change From Baseline in Micro-RNA-124 (miR-124) Expression in Peripheral Blood Mononuclear Cells (PBMCs)

Change from baseline in miR-124 expression in PBMCs will be assessed.

Time frame
Day 1 at predose, and at 12 hours, on Day 5 at predose, and on Day 7 at predose, and at 12 hours post-last dose
2

MAD Part: Change From Baseline in Interleukin (IL)-6, Tumor Necrosis Factor Alpha (TNF-α), IL-17A, and Interferon Gamma (IFN-γ) in Blood Serum

Change from baseline in IL-6, TNF-α, IL-17A, and IFN-γ in blood serum will be assessed.

Time frame
Day 1 at predose, and at 12 hours, on Day 5 at predose, and on Day 7 at predose, and at 12 hours post-last dose

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu Carephar Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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