Healthy VolunteersPhase 1NCT01374503
First in Man Study of ALX-0651, a Nanobody Inhibiting CXCR4
A Phase 1 study testing ALX-0651 in people with Healthy Volunteers, run by Ablynx, a Sanofi company at 1 site in Netherlands.
Trial summary
The purpose of this first-in-man Phase I study is to determine whether the CXCR4-inhibitor ALX-0651 is safe and effective after single or multiple intravenous administrations to healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ALX-0651
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2011to Jan 2012
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers, aged >= 18 and <= 55 at screening.
- Willing to consent to using an effective contraceptive method for at least 3 months after test substance administration.
- Non-smokers, or ex-smokers abstinent from tobacco for at least 1 year.
- Body mass index (BMI): 19 - 29 kg/m2 (extremes included).
- Haematology and chemistry parameters within normal range or showing no clinically relevant deviations, as judged by the Medical Investigator. For haematology, haemoglobin and white blood cell (WBC) count must be within normal limits. For chemistry, calcium, alkaline phosphatase (ALP), (alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT) and lactate dehydrogenase (LDH) must be within normal limits.
- Normal electrocardiogram, showing no clinically relevant deviations, as judged by the Investigator. QTc <= 450 ms.
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- No history or presence of diseases of the kidneys, heart, lungs, liver, gastrointestinal tract or endocrine organs, or other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- No history of clinically relevant allergies.
- Obtained, signed and dated informed consent.
- Ability and willingness to comply with protocol requirements.
Who cannot join
- Intake of any prescribed systemic or topical medication within 14 days prior to dosing.
- Intake of vitamin A derivates or retinoids within 30 days prior to the start of drug administration.
- History of thrombosis.
- Chronic infection or acute significant infection or fever within the last 5 weeks prior to the start of test substance administration.
- Subjects with any abnormality of the spleen (confirmed by echography) or history of splenic disease, or subjects that underwent splenectomy in the past.
- Blood donation (>500 ml) or a comparable blood loss within three months prior to the start of drug administration.
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- Subjects who, in the investigator's opinion, may not be capable of following the study schedule for any reason, with special emphasis on eligibility for the aphaeresis procedure.
- Participation in an investigational drug study within 60 days prior to drug administration, or within less than 6 times the terminal elimination half-life of the test substance used in the respective trial (whichever is longer).
- Malignancy, or prior malignancy, with a disease-free interval of < 5 years after diagnosis and intervention, except curative treatment for non-melanoma skin cancer or resected carcinoma in situ.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-centre, Randomised, Single-blinded, Placebo-controlled Single Ascending Dose Study, Followed by an Open-label Extension, Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of ALX-0651, Administered Intravenously to Healthy Male Volunteers
The purpose of this first-in-man Phase I study is to determine whether the CXCR4-inhibitor ALX-0651 is safe and effective after single or multiple intravenous administrations to healthy male volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- ALX-0651, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALX-0651Biological
single or multiple (once daily for maximum 3 consecutive days) i.v. administration, 0.003-12 mg/kg
PlaceboBiological
single or multiple i.v. administration
| Study group | Role | What they receive |
|---|---|---|
| ALX-0651 | Experimental | Not described Receives: Biological: ALX-0651 |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events
Measured: until 1 month after study drug administration
Secondary outcomes (2)
maximum plasma concentration (Cmax) of ALX-0651
Plasma concentration of ALX-0651 will be determined at different timepoints between predose and 48 hours after the last study drug administration. The maximum plasma concentration (Cmax) of ALX-0651 will be derived from the resulting plasma concentration versus time plots.
Measured: from predose until 48 hours after study drug administration
CD34 positive cell count in blood
Measured: from predose until 14 days after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Proof of principle established with completed SAD part
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ablynx, a Sanofi company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Josefin-Beate Holz, MD, Study director, Ablynx NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374503
- Sponsor's protocol ID
- ALX-0651-1.1/11
- Status last verified
- Apr 2012
- First submitted
- 14 Jun 2011
- Last updated
- 17 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-centre, Randomised, Single-blinded, Placebo-controlled Single Ascending Dose Study, Followed by an Open-label Extension, Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of ALX-0651, Administered Intravenously to Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01374503
- Acronym / sponsor ID
- ALX-0651-1.1/11
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Proof of principle established with completed SAD part
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ablynx, a Sanofi companyIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 16 Jun 2011 (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 purpose of this first-in-man Phase I study is to determine whether the CXCR4-inhibitor ALX-0651 is safe and effective after single or multiple intravenous administrations to healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALX-0651 | Experimental | Biological: ALX-0651 |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy male volunteers, aged >= 18 and <= 55 at screening.
- Willing to consent to using an effective contraceptive method for at least 3 months after test substance administration.
- Non-smokers, or ex-smokers abstinent from tobacco for at least 1 year.
- Body mass index (BMI): 19 - 29 kg/m2 (extremes included).
- Haematology and chemistry parameters within normal range or showing no clinically relevant deviations, as judged by the Medical Investigator. For haematology, haemoglobin and white blood cell (WBC) count must be within normal limits. For chemistry, calcium, alkaline phosphatase (ALP), (alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT) and lactate dehydrogenase (LDH) must be within normal limits.
Key exclusion criteria (9 listed)
- Intake of any prescribed systemic or topical medication within 14 days prior to dosing.
- Intake of vitamin A derivates or retinoids within 30 days prior to the start of drug administration.
- History of thrombosis.
- Chronic infection or acute significant infection or fever within the last 5 weeks prior to the start of test substance administration.
- Subjects with any abnormality of the spleen (confirmed by echography) or history of splenic disease, or subjects that underwent splenectomy in the past.
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 |
|---|---|---|
| ALX-0651single or multiple (once daily for maximum 3 consecutive days) i.v. administration, 0.003-12 mg/kg | Biological | ALX-0651 |
| Placebosingle or multiple i.v. administration | Biological | Placebo |
Primary outcome
Number of treatment emergent adverse events
Time frame: until 1 month after study drug administration
2 secondary outcomes
maximum plasma concentration (Cmax) of ALX-0651
Time frame: from predose until 48 hours after study drug administration
CD34 positive cell count in blood
Time frame: from predose until 14 days after study drug administration
Results and safety
The study was stopped early (reason given: Proof of principle established with completed SAD part). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2012.
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Screening Protocol
Pain
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.
Josefin-Beate Holz, MD study director
Ablynx NV
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 ALX-0651 in people with Healthy Volunteers, run by Ablynx, a Sanofi company at 1 site in Netherlands.
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 10 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: stopped early, as of the sponsor's last update on 17 Apr 2012. 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 Netherlands. 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 was stopped early (reason given: Proof of principle established with completed SAD part). Results are not available in the source record.
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 treatment emergent adverse events (time frame: until 1 month after study drug administration). 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 17 Apr 2012.