PNHPhase 1NCT05095168
Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Single Ascending Dose (SAD) of CAN106 Administered Intravenously (IV) in Healthy Subjects
A Phase 1 study testing CAN106 in people with PNH, run by CARE Pharma Shanghai Ltd. at 1 site in Singapore.
Trial summary
This is a single site, single dose escalation study in healthy subject with CAN106. The study is to assess the safety and tolerability of single escalating doses of CAN106; to characterize the PK and PD profile of CAN106; and to evaluate the immunogenicity of CAN106 injection. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- PNH
- What is being tested?
- CAN106
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteSingapore
- Study dates
- 22 Feb 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must be able to understand and provide informed consent.
- Males or females, between 21 and 45 years of age, inclusive;
- Body mass index must be within the range of 18.5 to 32.0 kg/m2;
- 12-lead electrocardiogram (ECG) within normal limits with no clinically significant abnormalities in the opinion of the Investigator；
- Systolic blood pressure ≤140 mmHg and a diastolic blood pressure of ≤ 90 mmHg after 5 minutes with supine rest；
- non-pregnancy
- meningococcal vaccinations for at least 2 weeks before dosing
Who cannot join
- Disease or conditions interfere with participating the trial
- Active serious mental illness or psychiatric disorder
- clinically relevant abnormal test results in hepatic function
- unacceptable CBC lab test
- asymptomatic complement deficiency
- Any other clinical safety laboratory test
Show all 9Show fewer
- HIV, HBV, HCV positive
- Alcohol and drug abuse
- etc.
Trial locations and contacts
1 site in 1 country.
About this study
This is a single site, single dose escalation study in healthy subject with CAN106. The study is to assess the safety and tolerability of single escalating doses of CAN106; to characterize the PK and PD profile of CAN106; and to evaluate the immunogenicity of CAN106 injection.
- Conditions
- PNH
- Being tested
- CAN106, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAN106Drug
CAN106 is a selective inhibitor of complement activation, which binds to the complement component C5.
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose (SAD) | Experimental | In the SAD arm subjects will be sequentially included in one of up to six cohorts (dose levels). Additional subjects may be added in any cohort if necessary. Receives: Drug: CAN106 |
| placebo | Placebo comparator | In the SAD arm subjects will be sequentially included in one of up to six cohorts (dose levels). In higher dose levels, subjects will be randomized to receive the treatment or placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of subjects with dose-limiting toxicity (DLTs)
TEAEs will be categorized as per the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria.
a DLT is defined as one subject with a Grade 3 AE or higher, that are assessed as drug-related by the site investigator.
Measured: 6-months after dosing
Incidence of adverse events (AEs)
An AE is defined as any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Measured: 6-months after dosing
Incidence of severe adverse events (SAEs)
Any untoward medical occurrence that at any dose:
- Results in death,
- Is life-threatening,
- Requires inpatient hospitalization or prolongation of existing hospitalization,
- Results in persistent or significant disability/incapacity, or
- Is a congenital anomaly/birth defect. (ICH E6 (R2))
Measured: 6-months after dosing
Secondary outcomes (8)
PK parameters - tmax
time to reach maximum of concentration (days)
Measured: 6-months after dosing
PK parameters-Cmax
peak plasma concentration
Measured: 6-months after dosing
PK parameters - AUC0-t
Area under the plasma concentration versus time curve to the last visit (AUCt)
Measured: 6-months after dosing
PK parameters - t1/2
terminal elimination half-life
Measured: 6-months after dosing
PD endpoints-free C5
maximal change from baseline in free C5 concentrations at each of scheduled post baseline assessment time-points (µg/ml);
Measured: 6-months after dosing
PD endpoints-CH50
maximal change from baseline total complement activity (CH50) at each of scheduled post baseline assessment time-points (%);
Measured: 6-months after dosing
PD endpoints-total C5
meausure the absolute change from baseline in total C5 concentrations at each of scheduled post baseline assessment time-points (µg/ml);
Measured: 6-months after dosing
Immunogenicity
Anti-drug Antibody (ADA) titers
Measured: 6-months after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start22 Feb 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 PNHStudies 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- CARE Pharma Shanghai Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095168
- Sponsor's protocol ID
- CAN106-HV-101
- Status last verified
- May 2022
- First submitted
- 22 Sep 2021
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Single Ascending Dose (SAD) of CAN106 Administered Intravenously (IV) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05095168
- Acronym / sponsor ID
- CAN106-HV-101
- Conditions
- PNH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- CARE Pharma Shanghai Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 27 Oct 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 single site, single dose escalation study in healthy subject with CAN106. The study is to assess the safety and tolerability of single escalating doses of CAN106; to characterize the PK and PD profile of CAN106; and to evaluate the immunogenicity of CAN106 injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose (SAD) | Experimental | Drug: CAN106In the SAD arm subjects will be sequentially included in one of up to six cohorts (dose levels). Additional subjects may be added in any cohort if necessary. |
| placebo | Placebo comparator | Drug: PlaceboIn the SAD arm subjects will be sequentially included in one of up to six cohorts (dose levels). In higher dose levels, subjects will be randomized to receive the treatment or placebo. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects must be able to understand and provide informed consent.
- Males or females, between 21 and 45 years of age, inclusive;
- Body mass index must be within the range of 18.5 to 32.0 kg/m2;
- 12-lead electrocardiogram (ECG) within normal limits with no clinically significant abnormalities in the opinion of the Investigator；
- Systolic blood pressure ≤140 mmHg and a diastolic blood pressure of ≤ 90 mmHg after 5 minutes with supine rest；
Key exclusion criteria (9 listed)
- Disease or conditions interfere with participating the trial
- Active serious mental illness or psychiatric disorder
- clinically relevant abnormal test results in hepatic function
- unacceptable CBC lab test
- asymptomatic complement deficiency
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 |
|---|---|---|
| CAN106CAN106 is a selective inhibitor of complement activation, which binds to the complement component C5. | Drug | Single Ascending Dose (SAD) |
| Placeboplacebo | Drug | placebo |
Primary outcome
Incidence of subjects with dose-limiting toxicity (DLTs)
Time frame: 6-months after dosing
TEAEs will be categorized as per the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria. a DLT is defined as one subject with a Grade 3 AE or higher, that are assessed as drug-related by the site investigator.
Incidence of adverse events (AEs)
Time frame: 6-months after dosing
An AE is defined as any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Incidence of severe adverse events (SAEs)
Time frame: 6-months after dosing
Any untoward medical occurrence that at any dose: * Results in death, * Is life-threatening, * Requires inpatient hospitalization or prolongation of existing hospitalization, * Results in persistent or significant disability/incapacity, or * Is a congenital anomaly/birth defect. (ICH E6 (R2))
8 secondary outcomes
PK parameters - tmax
Time frame: 6-months after dosing
PK parameters-Cmax
Time frame: 6-months after dosing
PK parameters - AUC0-t
Time frame: 6-months after dosing
PK parameters - t1/2
Time frame: 6-months after dosing
PD endpoints-free C5
Time frame: 6-months after dosing
PD endpoints-CH50
Time frame: 6-months after dosing
PD endpoints-total C5
Time frame: 6-months after dosing
Immunogenicity
Time frame: 6-months after dosing
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 25 May 2022.
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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 CAN106 in people with PNH, run by CARE Pharma Shanghai Ltd. at 1 site in Singapore.
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 7 inclusion and 9 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 25 May 2022. 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 Singapore. 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 subjects with dose-limiting toxicity (DLTs) (time frame: 6-months after dosing). The study lists 3 primary outcomes in all. 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 25 May 2022.