HealthyPhase 1NCT01165502
Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Multiple Ascending Doses of CM3.1-AC100 in Healthy Male Volunteers
A Phase 1 study testing CM3.1-AC100 in people with Healthy, run by CellMed AG, a subsidiary of BTG plc. at 1 site in Germany.
Trial summary
The primary objective is to assess the safety and tolerability of the GLP-1 peptide analogue CM3.1-AC100 after repeated subcutaneous (sc) doses. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CM3.1-AC100
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2010to Nov 2010
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated informed consent prior to any study specific procedures;
- Male volunteer aged 18 to 50 years at Screening, both inclusive;
- Body weight between 60.0 to 100.0 kg (both inclusive) and BMI 19 to 29.9 kg/m2 (both inclusive)
Who cannot join
- Any history or presence of a clinically relevant disease as judged to be relevant by the Investigator: cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, ocular or infectious disease and any acute infectious disease or signs of acute illness;
- Blood donation within 3 month before administration of the IP;
- Presence or history of drug allergy, or allergic disease diagnosed and treated by a physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-centre, Randomised, Double-blind, Placebo-controlled Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Multiple Ascending Doses of CM3.1-AC100 in Healthy Male Volunteers
The primary objective is to assess the safety and tolerability of the GLP-1 peptide analogue CM3.1-AC100 after repeated subcutaneous (sc) doses.
- Conditions
- Healthy
- Being tested
- CM3.1-AC100, Placebo
- Keywords
- MAD study CM3.1-AC100, Healthy men, age 18 - 50
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM3.1-AC100Drug
MAD study with repeated subcutaneous (sc) doses
PlaceboDrug
Placebo for compound CM3.1-AC100 s.c.
| Study group | Role | What they receive |
|---|---|---|
| CM3.1-AC100 | Experimental | Compound CM3.1-AC100 s.c. Receives: Drug: CM3.1-AC100 |
| Placebo | Placebo comparator | Placebo for compound CM3.1-AC100 s.c. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measurements (Adverse events, ECG recordings, blood pressure, pulse, body temperature, laboratory variables, local tolerability, Nausea Intensity, anti- CM3.1-AC100 antibodies)
Measured: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study
Secondary outcomes (1)
Pharmacokinetic samples for CM3.1-AC100
Pharmacokinetics:
Following the first dosing on Day 1:
AUC, AUC0-t, AUC0-9h, Cmax, tmax, t1/2λz, λz, CL/F, Vz/F of CM3.1-AC100.
Following multiple dosing on Day 7:
AUCss, AUCss,0-t, AUCss,0-9h, Css,max, Css, min, tss,max, t1/2λz,ss, λz,ss, CLss/F, Vz,ss/F, of CM3.1-AC100.
Measured: Intense PK-sampling during the 15 hours following administration of CM3.1-AC100 during day 1 and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2010
- Study completionNov 2010
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CellMed AG, a subsidiary of BTG plc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter Geigle, Dr. med., Study chair, CellMed AG, a subsidiary of BTG plc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165502
- Sponsor's protocol ID
- CellMed CM3.1-AC100/02
- Other IDs
- 2010-020512-11
- Status last verified
- Jan 2011
- First submitted
- 16 Jul 2010
- Last updated
- 19 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-centre, Randomised, Double-blind, Placebo-controlled Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Multiple Ascending Doses of CM3.1-AC100 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01165502
- Acronym / sponsor ID
- CellMed CM3.1-AC100/02
- Conditions
- Healthy
- Keywords
- MAD study CM3.1-AC100, Healthy men, age 18 - 50
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- CellMed AG, a subsidiary of BTG plc.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 20 Jul 2010 (estimated)
- 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.
The primary objective is to assess the safety and tolerability of the GLP-1 peptide analogue CM3.1-AC100 after repeated subcutaneous (sc) doses.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CM3.1-AC100 | Experimental | Drug: CM3.1-AC100Compound CM3.1-AC100 s.c. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for compound CM3.1-AC100 s.c. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Provision of signed and dated informed consent prior to any study specific procedures;
- Male volunteer aged 18 to 50 years at Screening, both inclusive;
- Body weight between 60.0 to 100.0 kg (both inclusive) and BMI 19 to 29.9 kg/m2 (both inclusive)
Key exclusion criteria (3 listed)
- Any history or presence of a clinically relevant disease as judged to be relevant by the Investigator: cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, ocular or infectious disease and any acute infectious disease or signs of acute illness;
- Blood donation within 3 month before administration of the IP;
- Presence or history of drug allergy, or allergic disease diagnosed and treated by a physician
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 |
|---|---|---|
| CM3.1-AC100MAD study with repeated subcutaneous (sc) doses | Drug | CM3.1-AC100 |
| PlaceboPlacebo for compound CM3.1-AC100 s.c. | Drug | Placebo |
Primary outcome
Safety measurements (Adverse events, ECG recordings, blood pressure, pulse, body temperature, laboratory variables, local tolerability, Nausea Intensity, anti- CM3.1-AC100 antibodies)
Time frame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study
1 secondary outcome
Pharmacokinetic samples for CM3.1-AC100
Time frame: Intense PK-sampling during the 15 hours following administration of CM3.1-AC100 during day 1 and day 7
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 19 Jan 2011.
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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.
Peter Geigle, Dr. med. study chair
CellMed AG, a subsidiary of BTG plc.
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 CM3.1-AC100 in people with Healthy, run by CellMed AG, a subsidiary of BTG plc. at 1 site in Germany.
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 3 inclusion and 3 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 19 Jan 2011. 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 Germany. 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?
Safety measurements (Adverse events, ECG recordings, blood pressure, pulse, body temperature, laboratory variables, local tolerability, Nausea Intensity, anti- CM3.1-AC100 antibodies) (time frame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study). 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 19 Jan 2011.