A Phase 1 interventional study of Hepalatide and Placebo in Hepatitis B， Chronic, sponsored by Shanghai HEP Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-14.
Sponsored by Shanghai HEP Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment
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Among 375 studies in Hepatitis B, Chronic with a site in China — 89 open to participants now, 110 under way, 7 of them phase 3. Hepatitis B, Chronic · China.
Among the 375 studies in Hepatitis B, Chronic with a site in China, this one is the 228th largest by enrollment of the 273 interventional ones that give a count, is one of 16 that started in 2015, is one of 50 in phase 1, and was the 105th registered.
896 studies on the registry are indexed under Hepatitis B, Chronic; 153 are open to participants now.
Browse Hepatitis B, Chronic studies →89 of the 375 studies in Hepatitis B, Chronic with a site in China are open now. Recruiting first, the newest first:
Jiyan Liu · Sites in China
Ages 18–65
Fujian Shengdi Pharmaceutical Co., Ltd. · Sites in China
Ages 18+
Fujian Akeylink Biotechnology Co., Ltd. · Sites in China
Ages 35–65
Ausper Biopharma Co., Ltd. · Sites in China
Ages 18–65 · Healthy volunteers
Zhiliang Gao · Sites in China
Ages 18–65 · Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 97 Hepatitis B, Chronic studies recruiting now, 33 (34%) set no upper age limit and 59 (61%) stop at 75 or younger; 11 take children under 18; 13 take healthy volunteers.
This study: 18 Years to 45 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
375 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 62 · Phase 2 85 · Phase 3 27 · Phase 4 73
First in 2000; this study’s year is marked. 16 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 48 is below the median of 100 across 659 interventional studies indexed under Hepatitis B, Chronic.
Median enrollment 120 across the 273 interventional studies, 500 across the 99 observational. Of the 151 that completed or were terminated, 29 (19%) have results posted.
This tab as a report to print or save as PDF → With an account.
167 of 375 have an industry lead sponsor. The 10 most frequent:
Shanghai HEP Pharmaceutical Co., Ltd. is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Shanghai HEP Pharmaceutical Co., Ltd. has 4 studies filed under Hepatitis B, Chronic — fewer than ten, so there is no comparison to draw.
39 of the studies in Hepatitis B, Chronic with a site in China that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07090759Phase 3Fujian Akeylink Biotechnology Co., Ltd.To Evaluate the Efficacy, Safety and Population Pharmacokinetics of GST-HG141 in Patients With Chronic Hepatitis B (CHB) Who Have an Inadequate Response to Antiviral Drug Treatment | 2026-12-01 |
| NCT07246889Phase 3Ausper Biopharma Co., Ltd.Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogues (NAs)(AUSHINE) | 2026-12-18 |
| NCT07307586Phase 3Zhigang RenA Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatitis B | 2026-12-31 |
| NCT07203118Phase 3Xi'an Xintong Pharmaceutical Research Co.,Ltd.A Phase II/III of Hepenofovir Fumarate Tablets (HTS) for Chronic Hepatitis B | 2027-06-30 |
| NCT02863757Humanity and Health Research CentreFollow-up of Chronic Hepatitis B Patients With Comorbid Nonalcoholic Fatty Liver Disease | 2026-12 |
Add all 39 to your calendar (.ics) → With an account.
Among the 375 studies in Hepatitis B, Chronic with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
To evaluate the safety and tolerability of Hepalatide(L47) and characterize the clinical pharmacokinetics in healthy volunteers.
This is a randomized, double-blinded, dose escalating, phase Ia trial, which will be conducted in No. 302 Hospital of China. There are seven cohorts at dose of 0.21mg, 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg. The first cohort with 0.21mg is an open test with no placebo as control. All other healthy volunteers will be randomized into Hepalatide or placebo group at 4:1 rate, and will be received drug by abdominal subcutaneous injection and will be observed for 8 days.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepalatide 0.21mg, 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg
Drug: Hepalatide
Placebo 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg
Drug: Placebo
There are seven cohorts as follows 0.21mg, 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg. Dose of 0.21mg is a pilot trial with no placebo. At each dose level, healthy volunteers will be received treatment drug by abdominal subcutaneous injection at the first day and monitored for 8 days.
Also known as: treatment drug
There are six cohorts as follows 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg. At each dose level, healthy volunteers will be received control drug by abdominal subcutaneous injection at the first day and monitored for 8 days.
Also known as: control drug
Healthy participants with treatment-related adverse events as assessed by "guiding principle of grading standards for the adverse reactions in clinical trials of vaccine for prevention" or CTCAE v4.0
Time frame: half a year
Maximum Plasma Concentration (Cmax)
Time frame: half a year
Area under the plasma concentration versus time curve (AUC)
Time frame: half a year
half-time
Time frame: half a year
apparent volume of distribution
Time frame: half a year
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Oct 2015, a primary completion of Aug 2016 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hepalatide
Shanghai HEP Pharmaceutical Co., Ltd.