Primary Sclerosing CholangitisPhase 1NCT03099603
A Study of HTD1801 in Healthy Subjects
A Phase 1 study testing HTD1801 in people with Primary Sclerosing Cholangitis, run by HighTide Therapeutics (Hong Kong) Limited at 1 site in Australia.
Trial summary
This is a randomized, double blind, single center, ascending single dose study to evaluate the safety, tolerability, and PK of HTD1801. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Sclerosing Cholangitis
- What is being tested?
- HTD1801
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 24 Mar 2017to 3 Oct 2017
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥18 to ≤ 50 years
- Body mass index (BMI) ≥18.0 to ≤ 30.0 kg/m2
- Current non-user of any nicotine containing products (>6 months)
- Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for ≥12 months. The site will try to retrieve medical records to document the sterility, however, the absence of records will not exclude screening the participant. If medical records cannot be obtained, serum and urine pregnancy testing will be conducted. Postmenopausal status will be confirmed through testing of FSH levels ≥ 40 IU/mL at screening for amenorrheic female participants <50 years of age.
- Males must be surgically sterile (>30 days since vasectomy with no viable sperm), abstinent or if engaged in sexual relations with a child-bearing potential, the participant and his partner must be using an acceptable, highly effective, contraceptive method from Screening and for a period of 60 days after the last dose of Study Drug. Acceptable methods of contraception are the use of condoms and an effective contraceptive for the female partner that includes: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception, or intrauterine contraception/device). The Principal Investigator will assess the adequacy of methods of contraception on a case-by-case basis.
- Ability to provide written informed consent.
Who cannot join
- Participation in an investigational drug study within 30 days prior to dosing or 5 half-lives within the last dose of investigational product whichever is longer.
- Current use of any prescription or over-the-counter (OTC) medications, including herbal products and supplements, within 14 days prior to Day 1 or 5 half-lives, whichever is longer. [Use of ≤2 g per day of paracetamol (acetaminophen) is allowed prior to and during the study at Investigator discretion. The reason for use must be listed either in the subject's baseline information or as an adverse event.]
- Any use of non-steroid anti-inflammatory drugs (NSAIDs) within 7 days prior to dosing.
- History of any serious adverse reaction or hypersensitivity to any of the product components.
- Use of parenterally administered proteins or antibodies within 12 weeks of screening. (Note: Influenza vaccine will be allowed)
- Glucose-6-phosphate dehydrogenase(G6PD) deficiency.
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- History of weight loss > 5% in the 8 weeks prior to screening.
- History of any active infection, other than mild viral illness, within 30 days prior to dosing.
- History of alcohol or illicit drug abuse as judged by the Investigator within approximately 1 year
- Use of any nicotine-containing product within 6 months prior to Screening or at any time during the study and follow-up as confirmed by urine cotinine screening.
- Presence of clinically significant medical history, physical, laboratory, or ECG findings that, in the opinion of the Investigator, may potentially compromise the safety of the subject, or interfere with any aspect of study conduct or interpretation of results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First in Human, Randomized, Double-Blind Study to Assess Safety, Tolerability, and Pharmacokinetics of Single, Ascending Doses of HTD1801 in Healthy Subjects
This is a randomized, double blind, single center, ascending single dose study to evaluate the safety, tolerability, and PK of HTD1801.
- Conditions
- Primary Sclerosing Cholangitis
- Being tested
- HTD1801
- Medical subject headings
- Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTD1801Drug
A small molecular compound for the treatment of primary sclerosing cholangitis
| Study group | Role | What they receive |
|---|---|---|
| 0.5g | Placebo comparator | single dose of placebo to 2 healthy subjects or 0.5g HTD1801 to 6 healthy subjects Receives: Drug: HTD1801 |
| 1.0g | Placebo comparator | single dose of placebo to 2 healthy subjects or 1.0g HTD1801 to 6 healthy subjects Receives: Drug: HTD1801 |
| 2.0g | Placebo comparator | single dose of placebo to 2 healthy subjects or 2.0g HTD1801 to 6 healthy subjects Receives: Drug: HTD1801 |
| 4.0g | Placebo comparator | single dose of placebo to 2 healthy subjects or 4.0g HTD1801 to 6 healthy subjects Receives: Drug: HTD1801 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) after single dose
Incidence, severity and causality of AEs and SAEs
Measured: up to Day 30
Secondary outcomes (5)
HTD1801 plasma concentration levels after single dose
Concentration-Time data
Measured: 96 hours
Pharmacokinetics (PK) of HTD1801 in plasma after single dose - peak plasma concentration (Cmax)
PK parameters: Cmax
Measured: 96 hours
PK of HTD1801 in plasma after single dose - area under the plasma concentration vs. time curve (AUC)
PK parameters: AUC
Measured: 96 hours
PK of HTD1801 in plasma after single dose - time to peak plasma concentration (Tmax)
PK parameters: Tmax
Measured: 96 hours
PK of HTD1801 in plasma after single dose - half life (T1/2)
PK parameters: T1/2
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start24 Mar 2017
- Primary completion11 Jul 2017
- Study completion3 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sclerosing CholangitisStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- HighTide Therapeutics (Hong Kong) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janet Wong, Doctor, Principal investigator, Nucleus Network Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099603
- Sponsor's protocol ID
- 1801.PCT002
- Status last verified
- Aug 2026
- First submitted
- 14 Mar 2017
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not provided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First in Human, Randomized, Double-Blind Study to Assess Safety, Tolerability, and Pharmacokinetics of Single, Ascending Doses of HTD1801 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03099603
- Acronym / sponsor ID
- 1801.PCT002
- Conditions
- Primary Sclerosing Cholangitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- HighTide Therapeutics (Hong Kong) LimitedIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2017 (actual)
- Primary completion
- 11 Jul 2017 (actual)
- Study completion
- 3 Oct 2017 (actual)
- First posted
- 4 Apr 2017 (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.
This is a randomized, double blind, single center, ascending single dose study to evaluate the safety, tolerability, and PK of HTD1801.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.5g | Placebo comparator | Drug: HTD1801single dose of placebo to 2 healthy subjects or 0.5g HTD1801 to 6 healthy subjects |
| 1.0g | Placebo comparator | Drug: HTD1801single dose of placebo to 2 healthy subjects or 1.0g HTD1801 to 6 healthy subjects |
| 2.0g | Placebo comparator | Drug: HTD1801single dose of placebo to 2 healthy subjects or 2.0g HTD1801 to 6 healthy subjects |
| 4.0g | Placebo comparator | Drug: HTD1801single dose of placebo to 2 healthy subjects or 4.0g HTD1801 to 6 healthy subjects |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age ≥18 to ≤ 50 years
- Body mass index (BMI) ≥18.0 to ≤ 30.0 kg/m2
- Current non-user of any nicotine containing products (>6 months)
- Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for ≥12 months. The site will try to retrieve medical records to document the sterility, however, the absence of records will not exclude screening the participant. If medical records cannot be obtained, serum and urine pregnancy testing will be conducted. Postmenopausal status will be confirmed through testing of FSH levels ≥ 40 IU/mL at screening for amenorrheic female participants <50 years of age.
- Males must be surgically sterile (>30 days since vasectomy with no viable sperm), abstinent or if engaged in sexual relations with a child-bearing potential, the participant and his partner must be using an acceptable, highly effective, contraceptive method from Screening and for a period of 60 days after the last dose of Study Drug. Acceptable methods of contraception are the use of condoms and an effective contraceptive for the female partner that includes: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception, or intrauterine contraception/device). The Principal Investigator will assess the adequacy of methods of contraception on a case-by-case basis.
Key exclusion criteria (11 listed)
- Participation in an investigational drug study within 30 days prior to dosing or 5 half-lives within the last dose of investigational product whichever is longer.
- Current use of any prescription or over-the-counter (OTC) medications, including herbal products and supplements, within 14 days prior to Day 1 or 5 half-lives, whichever is longer. [Use of ≤2 g per day of paracetamol (acetaminophen) is allowed prior to and during the study at Investigator discretion. The reason for use must be listed either in the subject's baseline information or as an adverse event.]
- Any use of non-steroid anti-inflammatory drugs (NSAIDs) within 7 days prior to dosing.
- History of any serious adverse reaction or hypersensitivity to any of the product components.
- Use of parenterally administered proteins or antibodies within 12 weeks of screening. (Note: Influenza vaccine will be allowed)
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 |
|---|---|---|
| HTD1801A small molecular compound for the treatment of primary sclerosing cholangitis | Drug | 0.5g, 1.0g, 2.0g, 4.0g |
Primary outcome
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) after single dose
Time frame: up to Day 30
Incidence, severity and causality of AEs and SAEs
5 secondary outcomes
HTD1801 plasma concentration levels after single dose
Time frame: 96 hours
Pharmacokinetics (PK) of HTD1801 in plasma after single dose - peak plasma concentration (Cmax)
Time frame: 96 hours
PK of HTD1801 in plasma after single dose - area under the plasma concentration vs. time curve (AUC)
Time frame: 96 hours
PK of HTD1801 in plasma after single dose - time to peak plasma concentration (Tmax)
Time frame: 96 hours
PK of HTD1801 in plasma after single dose - half life (T1/2)
Time frame: 96 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No. Not provided
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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.
Janet Wong, Doctor principal investigator
Nucleus Network Ltd
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 HTD1801 in people with Primary Sclerosing Cholangitis, run by HighTide Therapeutics (Hong Kong) Limited 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 11 Aug 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) after single dose (time frame: up to Day 30). 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 11 Aug 2026.