First in Man Study of ALX-0651, a Nanobody Inhibiting CXCR4

NCT01374503 | Terminated Phase 1 DMC

• 1 other identifier: ALX-0651-1.1/11
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events

  until 1 month after study drug administration

Secondary Outcomes (2)

• maximum plasma concentration (Cmax) of ALX-0651

  from predose until 48 hours after study drug administration

• CD34 positive cell count in blood

  from predose until 14 days after study drug administration

Study Arms (2)

ALX-0651

EXPERIMENTAL

Biological: ALX-0651

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

ALX-0651 BIOLOGICAL

single or multiple (once daily for maximum 3 consecutive days) i.v. administration, 0.003-12 mg/kg

ALX-0651

Placebo BIOLOGICAL

single or multiple i.v. administration

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ablynx, a Sanofi company: lead

Study Sites (1)

Unknown Facility

Groningen, Netherlands

Location

Study Officials

• Josefin-Beate Holz, MD

  Ablynx NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2011
• First Posted: June 16, 2011
• Study Start: June 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 17, 2012

Record last verified: 2012-04

Locations

NL (1)