HealthyPhase 1NCT01010425
Pharmacokinetics and Pharmacodynamics of ACP-001 (TransCon PEG hGH)
A Phase 1 study testing ACP-001 (TransCon PEG hGH) and Human Growth Hormone in people with Healthy, run by Ascendis Pharma A/S at 1 site in Canada.
Trial summary
Double-blind, randomized, placebo and active controlled dose-ascending study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-001 (TransCon PEG hGH). Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ACP-001 (TransCon PEG hGH) and Human Growth Hormone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2009to May 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects
- 20 to 45 years old
- Body Mass Index of 18.5 kg/m2 and less than or equal to 29.9 kg/m2
- Others
Who cannot join
- Known history of hypersensitivity to human growth hormone (hGH)
- Known history of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, immunological, hepatic or renal disease, or malignancies
- Others
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose-ascending, Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ACP-001 (TransCon PEG hGH)
Double-blind, randomized, placebo and active controlled dose-ascending study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-001 (TransCon PEG hGH).
- Conditions
- Healthy
- Being tested
- ACP-001 (TransCon PEG hGH), Placebo, Human Growth Hormone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP-001 (TransCon PEG hGH)Drug
ACP-001, dose-level 1, s.c., single-dose
ACP-001 (TransCon PEG hGH)Drug
ACP-001, dose-level 2, s.c., single-dose
ACP-001 (TransCon PEG hGH)Drug
ACP-001, dose-level 3, s.c., single-dose
ACP-001 (TransCon PEG hGH)Drug
ACP-001, dose-level 4, s.c., single-dose
PlaceboDrug
Placebo, s.c., single-dose
Human Growth HormoneDrug
Human Growth Hormone, s.c., daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| ACP-001, dose-level 1 | Experimental | Not described Receives: Drug: ACP-001 (TransCon PEG hGH); Drug: Placebo; Drug: Human Growth Hormone |
| ACP-001, dose-level 2 | Experimental | Not described Receives: Drug: ACP-001 (TransCon PEG hGH); Drug: Placebo; Drug: Human Growth Hormone |
| ACP-001, dose-level 3 | Experimental | Not described Receives: Drug: ACP-001 (TransCon PEG hGH); Drug: Placebo; Drug: Human Growth Hormone |
| ACP-001, dose-level 4 | Experimental | Not described Receives: Drug: ACP-001 (TransCon PEG hGH); Drug: Placebo; Drug: Human Growth Hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability (adverse events, local reactions, immunogenicity)
Measured: 0-42 days
Pharmacokinetics; AUC and Cmax for hGH, TransCon-PEG hGH; and Pharmacodynamics measured by IGF-1 and IFG-BP
Measured: 0-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionFeb 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascendis Pharma A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ascendis Pharma, Study director, Ascendis Pharma A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010425
- Sponsor's protocol ID
- ACP-001 (Prot. 3695)
- Status last verified
- Jun 2010
- First submitted
- 6 Nov 2009
- Last updated
- 8 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gilfoyle D, Mortensen E, Christoffersen ED, Leff JA, Beckert M. A first-in-man phase 1 trial for long-acting TransCon Growth Hormone. Growth Horm IGF Res. 2018 Apr;39:34-39. doi: 10.1016/j.ghir.2017.12.002. Epub 2017 Dec 5.
PubMed 29273485
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-ascending, Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ACP-001 (TransCon PEG hGH)
- ClinicalTrials.gov ID
- NCT01010425
- Acronym / sponsor ID
- ACP-001 (Prot. 3695)
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ascendis Pharma A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 10 Nov 2009 (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.
Double-blind, randomized, placebo and active controlled dose-ascending study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-001 (TransCon PEG hGH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ACP-001, dose-level 1 | Experimental | Drug: ACP-001 (TransCon PEG hGH), Drug: Placebo, Drug: Human Growth Hormone |
| ACP-001, dose-level 2 | Experimental | Drug: ACP-001 (TransCon PEG hGH), Drug: Placebo, Drug: Human Growth Hormone |
| ACP-001, dose-level 3 | Experimental | Drug: ACP-001 (TransCon PEG hGH), Drug: Placebo, Drug: Human Growth Hormone |
| ACP-001, dose-level 4 | Experimental | Drug: ACP-001 (TransCon PEG hGH), Drug: Placebo, Drug: Human Growth Hormone |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects
- 20 to 45 years old
- Body Mass Index of 18.5 kg/m2 and less than or equal to 29.9 kg/m2
- Others
Key exclusion criteria (3 listed)
- Known history of hypersensitivity to human growth hormone (hGH)
- Known history of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, immunological, hepatic or renal disease, or malignancies
- Others
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 |
|---|---|---|
| ACP-001 (TransCon PEG hGH)ACP-001, dose-level 1, s.c., single-dose | Drug | ACP-001, dose-level 1 |
| ACP-001 (TransCon PEG hGH)ACP-001, dose-level 2, s.c., single-dose | Drug | ACP-001, dose-level 2 |
| ACP-001 (TransCon PEG hGH)ACP-001, dose-level 3, s.c., single-dose | Drug | ACP-001, dose-level 3 |
| ACP-001 (TransCon PEG hGH)ACP-001, dose-level 4, s.c., single-dose | Drug | ACP-001, dose-level 4 |
| PlaceboPlacebo, s.c., single-dose | Drug | ACP-001, dose-level 1, ACP-001, dose-level 2, ACP-001, dose-level 3, ACP-001, dose-level 4 |
| Human Growth HormoneHuman Growth Hormone, s.c., daily for 7 days | Drug | ACP-001, dose-level 1, ACP-001, dose-level 2, ACP-001, dose-level 3, ACP-001, dose-level 4 |
Primary outcome
Safety and Tolerability (adverse events, local reactions, immunogenicity)
Time frame: 0-42 days
Pharmacokinetics; AUC and Cmax for hGH, TransCon-PEG hGH; and Pharmacodynamics measured by IGF-1 and IFG-BP
Time frame: 0-28 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 8 Jun 2010.
- Derived from this study: PubMed 29273485Gilfoyle D, Mortensen E, Christoffersen ED, Leff JA, Beckert M. A first-in-man phase 1 trial for long-acting TransCon Growth Hormone. Growth Horm IGF Res. 2018 Apr;39:34-39. doi: 10.1016/j.ghir.2017.12.002. Epub 2017 Dec 5.
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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.
Ascendis Pharma study director
Ascendis Pharma A/S
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 ACP-001 (TransCon PEG hGH) and Human Growth Hormone in people with Healthy, run by Ascendis Pharma A/S at 1 site in Canada.
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 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 8 Jun 2010. 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 Canada. 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. 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 and Tolerability (adverse events, local reactions, immunogenicity) (time frame: 0-42 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01010425, which also lists 1 linked publication.
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 8 Jun 2010.