HealthyPhase 1NCT05043792
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Dose of TT-00920 in Healthy Subjects
A Phase 1 study testing TT-00920 in people with Healthy, run by TransThera Sciences (Nanjing), Inc. at 1 site in United States.
Trial summary
This is a double-blind, randomized, placebo-controlled, multiple ascending dose escalation study of TT-00920 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TT-00920
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2021to 30 Nov 2021
- 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
- Written informed consent must be obtained
- Age ≥ 18.0 years and ≤ 55.0 years, male or female
- BMI between 18.0 and 30.0 kg/m2, inclusive, and weighs at least 50.0 kg
- No clinically significant findings in medical examination
Who cannot join
- Known hypersensitivity or allergy to lactose
- Vaccination with any live vaccine, or vaccination employing an mRNA platform within 28 days and/or vaccination with any inactivated vaccine within 7 days of study drug administration
- Impaired cardiac function including clinically significant arrhythmias or clinically significant abnormality
- HbA1c > 5.7 % at Screening
- Subject with a history of severe visual diseases; or visual changes
- Subject is unable to complete this study for other reasons or the Investigator believes that he or she should be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study of TT-00920 in Healthy Subjects
This is a double-blind, randomized, placebo-controlled, multiple ascending dose escalation study of TT-00920 in healthy subjects.
Read the detailed description
This is a double-blind, randomized, placebo-controlled, multiple ascending dose escalation study of TT-00920 in healthy subjects. Each dosing cohort will be comprised of 10 randomized subjects dosed three times daily for 13 days and one time for 1 day. The study will consist of a Screening Period, an In-house Period and a Follow-up.
- Conditions
- Healthy
- Being tested
- TT-00920, TT-00920 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TT-00920Drug
TT-00920 Tablets
TT-00920 PlaceboDrug
TT-00920 Placebo Tablets
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 (Low dose) | Active comparator | TT-00920, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14. Receives: Drug: TT-00920 |
| Dose 2 (High dose) | Active comparator | TT-00920, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14. Receives: Drug: TT-00920 |
| Placebo | Placebo comparator | TT-00920 Placebo, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14. Receives: Drug: TT-00920 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of TEAEs and clinically relevant changes in safety parameters,e.g. clinical laboratory tests, 12-lead ECG, ophthalmological examination [Safety and tolerability]
- TEAE: Treatment emergent adverse events
- Safety parameters: physical examinations, vital signs, clinical laboratory tests , 12-lead ECG in triplicate, cardiac Holter monitoring, visual tests and ophthalmological examinations
Measured: 14 days
Secondary outcomes (10)
Area under the plasma drug concentration versus time curve at steady state (AUC0-t, ss and AUC0-τ, ss)
Measured: 14 days
Maximum observed plasma concentration at steady state (Cmax, ss)
Measured: 14 days
Time corresponding to occurrence of Cmax,ss at steady state (Tmax, ss)
Measured: 14 days
Minimum observed plasma concentration at steady state (Cmin, ss)
Measured: 14 days
Trough plasma concentration (Ctrough)
Measured: 14 days
Accumulation ratio (Rac)
Measured: 14 days
Average concentration (Cav)
Measured: 14 days
Volume of distribution at steady state (Vz/F, ss)
Measured: 14 days
Clearance at steady state (CL/F, ss)
Measured: 14 days
Half-life at steady state (T1/2, ss)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start19 Aug 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- TransThera Sciences (Nanjing), Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043792
- Sponsor's protocol ID
- TT00920US03
- Status last verified
- Oct 2023
- First submitted
- 1 Sep 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study of TT-00920 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05043792
- Acronym / sponsor ID
- TT00920US03
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- TransThera Sciences (Nanjing), Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 14 Sep 2021 (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 double-blind, randomized, placebo-controlled, multiple ascending dose escalation study of TT-00920 in healthy subjects.
Detailed description
This is a double-blind, randomized, placebo-controlled, multiple ascending dose escalation study of TT-00920 in healthy subjects. Each dosing cohort will be comprised of 10 randomized subjects dosed three times daily for 13 days and one time for 1 day. The study will consist of a Screening Period, an In-house Period and a Follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose 1 (Low dose) | Active comparator | Drug: TT-00920TT-00920, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14. |
| Dose 2 (High dose) | Active comparator | Drug: TT-00920TT-00920, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14. |
| Placebo | Placebo comparator | Drug: TT-00920 PlaceboTT-00920 Placebo, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Written informed consent must be obtained
- Age ≥ 18.0 years and ≤ 55.0 years, male or female
- BMI between 18.0 and 30.0 kg/m2, inclusive, and weighs at least 50.0 kg
- No clinically significant findings in medical examination
Key exclusion criteria (6 listed)
- Known hypersensitivity or allergy to lactose
- Vaccination with any live vaccine, or vaccination employing an mRNA platform within 28 days and/or vaccination with any inactivated vaccine within 7 days of study drug administration
- Impaired cardiac function including clinically significant arrhythmias or clinically significant abnormality
- HbA1c > 5.7 % at Screening
- Subject with a history of severe visual diseases; or visual changes
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 |
|---|---|---|
| TT-00920TT-00920 Tablets | Drug | Dose 1 (Low dose), Dose 2 (High dose) |
| TT-00920 PlaceboTT-00920 Placebo Tablets | Drug | Placebo |
Primary outcome
Incidence of TEAEs and clinically relevant changes in safety parameters,e.g. clinical laboratory tests, 12-lead ECG, ophthalmological examination [Safety and tolerability]
Time frame: 14 days
* TEAE: Treatment emergent adverse events * Safety parameters: physical examinations, vital signs, clinical laboratory tests , 12-lead ECG in triplicate, cardiac Holter monitoring, visual tests and ophthalmological examinations
10 secondary outcomes
Area under the plasma drug concentration versus time curve at steady state (AUC0-t, ss and AUC0-τ, ss)
Time frame: 14 days
Maximum observed plasma concentration at steady state (Cmax, ss)
Time frame: 14 days
Time corresponding to occurrence of Cmax,ss at steady state (Tmax, ss)
Time frame: 14 days
Minimum observed plasma concentration at steady state (Cmin, ss)
Time frame: 14 days
Trough plasma concentration (Ctrough)
Time frame: 14 days
Accumulation ratio (Rac)
Time frame: 14 days
Average concentration (Cav)
Time frame: 14 days
Volume of distribution at steady state (Vz/F, ss)
Time frame: 14 days
Clearance at steady state (CL/F, ss)
Time frame: 14 days
Half-life at steady state (T1/2, ss)
Time frame: 14 days
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 18 Nov 2023.
- Individual participant dataSharing planned: No
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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 TT-00920 in people with Healthy, run by TransThera Sciences (Nanjing), Inc. at 1 site in United States.
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 4 inclusion and 6 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 18 Nov 2023. 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 United States. 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?
Incidence of TEAEs and clinically relevant changes in safety parameters,e.g. clinical laboratory tests, 12-lead ECG, ophthalmological examination [Safety and tolerability] (time frame: 14 days). 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 18 Nov 2023.